Ponto The bone anchored hearing system from Oticon Medical. Audiological Manual. Ponto, Ponto Pro & Ponto Pro Power

Transcription

1 Ponto The bone anchored hearing system from Oticon Medical Audiological Manual US Ponto, Ponto Pro & Ponto Pro Power

2 Contents Introduction...3 Patient selection...4 Pre-operative evaluation and counseling... 8 Pediatrics...10 Product description Fitting procedure Accessories Post-fitting follow-up and evaluation Important patient information...18 Feature overview

3 Introduction The Ponto bone anchored hearing system is designed to give patients improved hearing through direct bone conduction. The Ponto sound processors convert sound into vibrations that are transmitted via the abutment and implant through the skull bone directly to the cochlea. The Ponto System works independently of the function of the ear canal and middle ear, and any conductive element of the hearing impairment is overcome. The Ponto System is a beneficial solution for several patient groups: Conductive or mixed hearing loss Studies indicate that patients with an air-bone gap of more than 30 db (PTA) will benefit significantly from a bone anchored sound processor as compared to an air conduction hearing aid. 1 Less amplification is required as the conductive loss is completely bypassed. Treatment process The implant is inserted into the skull bone behind the ear in a simple surgical procedure. After a short period of time, during which the bone attaches to the implant through osseointegration, the sound processor can be connected to the abutment. The Ponto sound processors may also be used on a head band or soft band by patients where the placement of a bone anchored implant is not suitable or in the period before the surgery is performed. The Ponto sound processors come in three models Ponto, Ponto Pro and Ponto Pro Power. Single-sided deafness/unilateral sensorineural deafness In patients with single-sided deafness (unilateral sensorineural deafness) the Ponto System will pick up sound from the deaf side and transfer it to the functioning cochlea on the opposite side. This will reduce the head shadow effect and improve speech intelligibility in noise, which is beneficial to many patients. 2 Chronically draining ears Instead of aggravating problems with infection and irritation by having a traditional hearing aid occluding the ear canal, the Ponto System gives high sound quality while keeping the ear canal completely open. 3

4 Patient selection Audiological indications Conductive or mixed hearing loss Patients with conductive or mixed hearing loss, who can still benefit from amplification of the sound, may be candidates for the bone anchored sound processor. The pure tone average bone conduction threshold for the indicated ear should be better than or equal to (measured at 0.5, 1, 2 and 3 khz): 45 db HL when fitting Ponto or Ponto Pro 55 db HL when fitting Ponto Pro Power Fitting range for Ponto and Ponto Pro Fitting range for Ponto Pro Power Treatment benefits Advantages compared to conventional air conduction hearing aids: The sound signals will bypass the conductive loss. This means that less amplification is needed, which has a positive effect on the sound quality. The ear canal remains completely open, which means that the situation for patients with ear infections and draining ears can be improved. Advantages compared to middle ear surgery: The bone anchored sound processor can be evaluated by the patient and audiologist before surgery. The implantation involves a surgical procedure that is simple, reversible and does not expose the patient to any risk of additional hearing impairment. Advantages compared to conventional bone conductors: Patient comfort is improved as there is no constant pressure against the skull. Sound quality is better as there is no attenuation of the signal passing through the skin. More discreet 4 Studies indicate that patients with an air-bone gap of more than 30 db (PTA) will benefit significantly from a Typical audiogram, bone anchored sound processor as compared to an air conductive hearing loss conduction hearing aid k 2k 4k 8k Typical audiogram, mixed hearing loss k 2k 4k 8k

5 Single-sided deafness (Unilateral sensorineural deafness) Patients who suffer from a profound sensorineural hearing loss in one ear with normal hearing in the opposite ear may be suitable candidates for a bone anchored hearing system. In this application the sound processor acts as a CROS drive. It is placed on the patient s deaf side to pick up sound that is transferred to the functioning cochlea on the opposite side. The pure tone average air conduction threshold of the hearing ear should be better than or equal to 20 db HL AC (measured at 0.5, 1, 2 and 3 khz). Fitting range for Ponto, Ponto Pro and Ponto Pro Power db HL AC k 2k 4k 8kHz Treatment benefits Single-sided deafness patients may benefit from a bone anchored sound processor in terms of reduced head shadow effect and improved speech intelligibility in noise. 2 Advantages compared to a an AC CROS aid: The ear canal remains completely open. No cables are needed for transmitting the sound to the hearing cochlea Typical audiogram, single-sided deafness k 2k 4k 8k The Ponto sound processors are also indicated for any patients who are candidates for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but for some reason cannot or will not use an AC CROS. 5

6 Pure sensorineural hearing loss in combination with an external otitis that contraindicates the use of an air conduction hearing aid The pure tone average bone conduction threshold for the indicated ear should be better than or equal to (measured at 0.5, 1, 2 and 3 khz): 45 db HL when fitting Ponto or Ponto Pro 55 db HL when fitting Ponto Pro Power Bilateral fittings Bilateral fitting is applicable for most patients with a symmetrical bone conduction threshold. The difference between the left and right sides bone conduction thresholds should be less than 10 db on average (measured at 0.5, 1, 2 and 4 khz), or less than 15 db at individual frequencies. Bilateral sound processors produce binaural hearing with improved sound localization and speech recognition in noise. 3 Head band / Soft band For children who are too young to have an implant placed and for other patients who are not suited for implantation, the sound processor can be used on a soft band or head band. (The soft band is an elastic band with a connection plate.) The sound processor is connected to the head band or soft band and works in a similar way to a conventional bone conductor. Due to the attenuation of the signal through the skin, patients with conductive or mixed hearing loss should then have a pure tone average bone conduction threshold of the indicated ear that is better than or equal to (measured at 0.5, 1, 2 and 3 khz): 25 db HL when fitting Ponto or Ponto Pro 35 db HL when fitting Ponto Pro Power Other indications A maximum speech discrimination score better than 60% when using a phonetic balanced word list is recommended, but an individual evaluation must always be made based on the patient s speech discrimination and his or her specific needs. Common medical background Chronically draining ears (external otitis, draining otitis media and radically operated ears) where conventional hearing aids aggravate infection or cause feedback problems, poor wearing comfort or poor sound quality. Skin allergies where an ear mold aggravates problems. Congenital malformations where ear canals are absent and cannot be restored through conventional surgery. Ear canal stenosis or previous ear surgery which makes and ear mold unsuitable. Conductive hearing loss due to ossicular disease that cannot be rectified, at all or to a sufficient extent, by surgical correction or conventional hearing aids. Sensorineural deafness in one ear and conductive hearing loss in the other, where surgery in the ear with conductive hearing loss is considered too risky. Unilateral sensorineural deafness caused by acoustic neuroma surgery, sudden deafness or other factors, and where an AC CROS is not feasible or desired. Note: Patient candidates should always be tested with the sound processor on a test band or test rod preoperatively to evaluate the benefit. 6

7 Cautions It is vital to be able to maintain proper hygiene around the abutment. Factors that affect this ability should be considered, as well as the possibilities of obtaining help to maintain sufficient hygiene, if necessary. In children the responsibility falls on the parents or caregiver. Patients with psychiatric disease, immature personality, drug or alcohol abuse, or who are unable to follow instructions or participate in continued follow-ups are unsuitable for treatment with a bone anchored hearing implant. Poor hygiene significantly increases the risk of adverse skin reactions. It is important that the patient develops realistic expectations through clear information about the treatment and about what a bone anchored hearing system may do for that individual patient. The patient must be provided with clear information about possible complications, aftercare requirements and precautions for the surgical procedure. Sufficient bone depth and bone quality must be present for a successful anchoring of the implant in the bone. The two-stage surgical procedure may be applied for patients with a bone depth of less than 3 mm, by using a modified surgical technique with for example a PTFE membrane. However, the individual assessment of each patient candidate must be carefully done and the surgical procedure performed with great care. Disease, history of irradiation or other factors that may affect the bone quality should always be considered in the individual assessment of the patient. Bone quality should be further examined by the surgeon when preparing the implant site. The skin area around the implant site should be prepared to a thin, hairless graft without any subcutaneous tissue, and with gentle slopes from the surrounding thick skin down to this area. The hairless thin skin area should be at least 20 mm in diameter. This is very important since thick skin around the implant makes it difficult for the patient to maintain good hygiene around the skin penetration, and because movement of the skin in relation to the abutment may cause skin irritation. The skin condition should always be considered. Patients with psoriasis or diabetic patients have not been reported to have an increased risk of implant loss or skin problems. Contraindications Inability to maintain, or lack of help with maintaining, sufficient hygiene around the abutment. Insufficient bone quality or bone thickness that will jeopardize the implant stability in the short or long term. This is for example the case with small children. In the US and Canada, the placement of a bone anchored implant is contraindicated in children below the age of five. Patients with poor bone quality or with a bone depth of 3 mm or below are contraindicated for the single stage surgical procedure. Note: Patients who are not suited or who are too young to receive a bone anchored implant may instead use the sound processor connected to a head band or soft band. Details on surgical and clinical aspects of patient selection and complications may be found in the surgical manual. 7

8 Pre-operative evaluation and counseling Throughout the evaluation and counseling process it is vital that surgeons and audiologists cooperate closely in order to achieve an optimal patient outcome from both a surgical and audiological perspective. Evaluation equipment To demonstrate the sound processor and to evaluate the benefits for the patients, the Ponto sound processors can be connected to any of the following test accessories: Test band a firm head spring with a connector plate. The test band is used when testing the sound processor for shorter periods, mainly inside the clinic or hospital. The sound processor is clicked onto the connector plate of the test band and the test band is placed around the patient s head. Make sure that the sound processor does not touch the pinna or hand as this will cause feedback. Head band a softer head spring than the test band. The head band can be used when testing the sound processor during longer periods, for example when the patient is sent home with the sound processor to evaluate the benefits for several days or weeks. It is also suitable for daily use by patients who are unsuitable for implantation but who can gain from using the sound processor as a traditional bone conductor. The sound processor and head band are connected in the same way as with the test band (see above). Test rod a connection rod that can be pressed against the head. The test rod is useful for demonstration and testing. Note: The hand must not touch the sound processor when holding the test rod since this will cause feedback. Pre-operative fitting It is recommended to fit the sound processor according to the patient s individual hearing loss. The Genie Medical fitting software has a dedicated fitting mode for soft band / head band, that automatically compensates for the attenuation of the signal through the skin. Time set aside for the pre-operative fitting is often limited, or there might be other reasons where an individual fitting may not be feasible. In such cases the Factory setting may be used (see page 20). Because the signal is attenuated through the skin it might be beneficial to use the Ponto Pro Power in the pre-operative evaluation, even when the patient has no or only a little cochlea hearing loss. Audiological measurements Pure tone and speech audiometry are the main measurements used to evaluate candidates for a bone anchored sound processor. The sound processor works independently of the air-bone gap. It is therefore the bone conduction threshold that determines whether the patient is within the sound processor fitting range (see audiological indications). For a patient candidate with unilateral sensorineural deafness it is recommended that the patient wears the sound processor on a soft band or head band in daily situations for at least a week to ensure that the sound processor offers the expected benefits. Counseling Realistic patient expectations It is vital that the patient develops realistic expectations through clear information about the treatment and what the Ponto System may do for that individual patient. In most cases a bone anchored sound processor leads to significantly improved sound quality, comfort and speech intelligibility. In some patients, however, this may not be the case. 8 Test band Head band Test rod

9 For patients with chronically draining ears, the main benefit may be reduced infection and a dry ear. The patient should be allowed to try the sound processor in different environments and situations using the test band or head band. Note: It is important to inform the patient that the sound performance will be further improved once the sound processor is connected to the abutment. The added gain can be expected to improve by 2-15 db from 1 khz and upwards after implant insertion, when the sound vibrations no longer have to pass through the skin. Important information for the patient It is important that the patient receives clear information about bone anchored hearing implants and sound processors, and about the pre-operative evaluation and treatment process. It may be useful for the patient to see and understand the actual size of the implant and abutment, and that only the small implant part will be placed inside the skull bone. It is also important to inform the patient about the treatment process including healing time and the time left for osseointegration before the sound processor can be fitted. The patient should understand the importance of maintaining sufficient hygiene around the abutment and what the patient will be required to do to ensure this (see information about hygiene and sound processor maintenance on page 15). Side selection For patients with a bilateral hearing loss fitted with a single sound processor, the side with the best cochlear function is preferable from an audiological point of view. In cases where it is difficult to determine which side is the best from the audiogram, the test band may help the patient tell which side is the best for placement of the sound processor. In addition to the audiological aspect, practical considerations, e.g. manual dexterity, cosmetics, hair growth and frequent situations in everyday life should also be considered when choosing the optimal side for implant placement. Telephone usage should be considered, and if the patient frequently drives a car with a passenger, the side facing the passenger may be the best alternative. Healing time before fitting Before connecting the sound processor to the abutment, a period of time should pass after surgery in order not to load the implant during the osseointegration period. During this period the bone anchors to the implant surface. A longer time period should be applied in the case of children and people with insufficient bone thickness or poor bone quality. (The required healing time is estimated by the surgeon during surgery. For more information about osseointegration and healing time, see Oticon Medical Surgical Manual.) Choice of sound processor Oticon Medical has three different sound processors, Ponto and Ponto Pro for BC hearing losses up to 45 db HL and Ponto Pro Power for BC hearing losses up to 55 db HL. The Ponto Pro and Ponto Pro Power contains additional advanced features such as automatic multiband adaptive directionality, noise reduction and learning volume control, see feature list on page 21. The Ponto sound processor does not include all the advanced functionalities that are available in Ponto Pro and Ponto Pro power, but has the same maximum force output as Ponto Pro. All three sound processors can be individually fitted using Genie Medical software. Note: The Ponto sound processors can be fitted on abutments from other manufacturers. For more information about products that can be used with the Ponto sound processors, see page 23. 9

10 Pediatrics Evaluating and fitting children with a bone anchored sound processor involves some special considerations. The soft band is a valuable tool for evaluation as well as for fitting before the implantation can be performed. Audiological indications The general audiological indications are applicable for children who are fitted with the sound processor on an abutment, see Audiological indications, page 4-6. When fitted on the soft band the child should have a pure tone average bone conduction threshold of the indicated ear that is better than or equal to (measured at 0.5, 1, 2 and 3 khz): 25 db HL when fitting Ponto or Ponto Pro 35 db HL when fitting Ponto Pro Power The difference from the general audiological indications is due to the attenuation of the signals through the skin. Evaluation & counseling Evaluation on the soft band The soft band is a useful tool for evaluating the benefits of the Ponto sound processors. Age appropriate tests should be used when evaluating audibility and speech understanding. Note: An improved hearing of 2-15 db can be expected once an implant is placed and a Ponto sound processor is fitted on the abutment. Parent counseling Parents of hearing impaired children generally have a great need for counseling. Issues related to the child s development are central and many parents need advice on what they can do to help their child in their social and language development. The treatment should be discussed with the parent from a short as well as long term perspective. Early access to hearing rehabilitation is crucial for the child s speech, language and educational development. The test rod is useful for demonstrating the bone conduction sound to the parent or caregiver. It is also included in the sound processor kit and can be used to demonstrate the sound to family and friends and to test that the sound processor is working. The parent or caregiver is responsible for maintaining appropriate hygiene in the area surrounding the abutment, as well as for the maintenance of the sound processor (see Hygiene and maintenance, page 15). Fitting on a soft band Before a bone anchored implant can be successfully placed the bone must be thick enough and sufficiently hard. For detailed information on required bone thickness and special consideration for pediatric patients, see the Oticon Medical Surgical Manual. It is recommended that children are fitted with the sound processor on a soft band during the period before reaching the appropriate age for implantation. With the soft band the child can be fitted early to gain from an improved language, speech and educational development. At the same time the treatment benefits can be evaluated while the decision to have an implant placed can be postponed until the child is older. Note: In the US and Canada, the placement of a bone anchored implant is contraindicated in children below the age of five. Individual fitting is particularly important for children. The Genie Medical fitting software has a dedicated fitting mode for soft band / head band that automatically compensates for the attenuation of the signal through the skin. Further choices can be made in the software to adjust the possibilities to use different controls (e.g. turn off volume control) according to what is judged best for the individual child. For more information, see Genie Medical Fitting Guide. 10

11 Long-term use of the soft band It is important that the child continues to associate the soft band with something positive. The periods of use can be extended gradually. If the child shows signs of discomfort it is a good idea to shorten the periods of use for a period of time. Instruct the parent or caregiver to rotate the soft band position regularly to prevent discomfort or soreness under the connection disc. In case of soreness the connector disc should not be placed in the sore area. If the soreness persists it may be necessary to discontinue the use of the soft band for a few days until the soreness disappears. It is important that the child s first experience with the soft band is positive. Turn on the sound processor and attach it to the connection disc on the soft band. Put the soft band around your own head and plug your ears to make sure that the sound processor is working. Note: For more information about how to use the soft band, please see separate soft band user manual. Put the soft band on the child s head, loosely at first, with the connection disc against the mastoid or some other bony part of the skull. Make sure that the whole disc is in contact with the skin. Avoid placing the disc against the temporal bone as this may be uncomfortable for the child. Tighten the soft band so that an effective sound transmission is achieved, but loose enough not to cause any discomfort. You should be able to put a finger between the soft band and the child s skull. Ask the parent or caregiver to talk to the child. It is important that the first sound experience is positive. Observe how the child reacts to the sound. 11

12 Product description 1. Push button for program selection and stand-by/mute 2. Volume control Ponto and Ponto Pro 1 Ponto Pro Power 1 3. DAI (Direct Audio input) connector 4. Microphones Inlet for programming Battery door, (on/off, tamper-resistant) Coupling 8. Hole for safety line 9. Labeling Right or left version The Ponto sound processors are available in a left and a right version. Each sound processor is marked with a L (left) or R (right) symbol on the battery door for easy identification The serial number of the sound processor can be seen when the battery door is open, using a magnifying glass, or when the sound processor is connected to the Genie Medical software. 12

13 Fitting procedure Fitting steps The fitting procedure involves the following steps: Checking the abutment and surrounding skin area (see below). applied. Tell the patient that in case of persistent soreness he or she must contact the clinic. It is easier to treat skin irritations or infections at an early stage. Individual fitting using Genie Medical fitting software (see page 14). Going through the user manual together with the patient to make sure the contents are understood (see sound processor User Manual). Practice connecting and disconnecting the sound processor. Practice operating the sound processor controls. Go through important patient information and warnings with the patient (see page 18-19). Explaining routines for hygiene and maintenance (see page 15). Arranging future follow-up appointment frequency (see page 17) and finding a time for the next appointment. Checking the abutment and surrounding skin area Try to gently rotate the abutment to see that it is stable. If the connection is not stable, refer the patient to a trained healthcare professional to have it tightened. Inspect the skin surrounding the abutment and remove any debris around or on the inside of the abutment. If there are any signs of skin irritation around the abutment a mild antibiotic cream/ointment should be 13

14 Individual fitting using Genie Medical All three sound processors, Ponto, Ponto Pro and Ponto Pro Power can be individually fitted to the patient s hearing loss using the Genie Medical fitting software. The initial recommended fitting steps includes: measuring the patient BC hearing threshold via the sound processor. measuring the individual feedback limit when fitting Ponto Pro Power, and for Ponto and Ponto Pro in case there is a feedback problem. The software will prescribe an individual gain setting for the patient. The sound processor settings and advanced features can then be further adjusted and individual programs can be added to optimize the sound processor for each patient. For more details see Genie Medical Fitting Guide. Finish the individual fitting procedure by filling in the fitted programs in the sound processor User Manual. This is also a good opportunity to note clinic contact information in the user manual. The Genie Medical software is NOAH compatible and can import audiograms from NOAH. A standard programming device (Hi-Pro or NOAH-link) is used to connect the sound processors to the PC. 14

15 Explaining routines for hygiene and maintenance It is vital to inform the patient about the importance of maintaining good hygiene in the area around the abutment of the bone anchored implant. Daily cleaning routines Instruct the patient to keep a simple daily cleaning routine using soap and water. In the period before the skin is fully healed, a non-alcoholic baby wipe can be used to clean the area around the abutment. Once healing has progressed sufficiently, an extra soft cleaning brush should be used towards the outside and inside of the abutment. Note the importance of cleaning both inside and all around the skin-penetrating abutment. This is important to prevent debris build-up. Antibacterial soap is recommended and the area may be dried with a non-alcoholic baby wipe. The cleaning brush should be replaced about once every 3 months. Cleaning every few days The skin should be thoroughly cleaned of debris every few days. While washing the hair with shampoo, debris becomes softer and is more easily removed. Maintenance of sound processor A dry cloth or baby wipe may be used to clean the outside of the sound processor when required. Special attention should be given to the coupling to remove any dirt or entangled hair. Service & Repair It is important that the patient handles the sound processor with care and maintains proper hygiene to avoid unnecessary service and repair. Recommendations for handling and precautions are given in the sound processor User Manual. Arranging follow-up Find a time for a first follow-up visit at approximately six weeks after the initial fitting. Explain the frequency of follow-up appointments that will be needed in the future and the purpose of these appointments (see page 17). Note: No water or liquids should be used when cleaning the sound processor, it is not waterproof! 15

16 Accessories The DAI connector allows for the connection of a telecoil or FM receiver directly to the sound processor, and Hi-Fi external equipment like MP3-players, radio or TV equipment via an audio adapter. Red dot Warning! An audio adapter with an isolation transformer which provides medical safety isolation (i.e. in conformity with IEC ) must always be used when connecting to any equipment which uses a power supply or battery with a voltage greater than 12V. Direct connection of any equipment with an electrical supply of higher than 12V is potentially dangerous and may prove fatal. When an isolated audio adapter is connected to mains-operated equipment, this equipment must comply with the electrical safety standards for consumer products (i.e. IEC or equivalent safety standards). External equipment must be connected so that the pin marked in red is facing the red mark on the DAI connector. Telecoil unit The telecoil offers the patient access to teleloop systems. T and MT programs for the sound processor can be defined and adjusted in the Genie Medical fitting software. Audio adapter The Audio adapter, with an isolation transformer, allows the patient to connect the sound processor to any audio unit with a headphone outlet (3.5 mm connector). This gives direct input to external Hi-Fi equipment such as stereos, MP3-players, television sets, FM and IR systems. DAI and DAI+M programs for the sound processor can be defined and adjusted in the Genie Medical fitting software. FM receiver unit Suitable FM receivers are available from Oticon and Phonak. For more details, please see the information from these suppliers. FM and FM+M programs for the sound processor can be defined and adjusted in the Genie Medical fitting software. Xpress coupling The Xpress allows the sound processor to be connected and disconnected from the abutment in a more gentle way. This function is very helpful for patients or parents/guardians who find the connection and disconnection of the sound processor uncomfortable due to the force required. It should be noted that the sound performance of the sound processor may be slightly reduced in the very high frequencies when using the Xpress, since the vibrations have to pass through the Xpress before reaching the abutment and implant. Note: It is recommended to use a safety line connected to the sound processor when using the Xpress since the sound processor may fall off more easily when the Xpress is used. 16

17 Post-fitting follow-up and evaluation To get the maximum benefit from Ponto, Ponto Pro or Ponto Pro Power it is recommended that the patient attends the follow-up sessions after the sound processor fitting. Checking the abutment At each follow-up appointment the abutment and surrounding skin should be inspected and any debris cleaned away in order to prevent infection. If the connection screw is not attached firmly to the implant, it may result in poor sound quality and skin irritation around the abutment. If needed the abutment connection screw should be tightened to a torque of 25 Ncm using a torque wrench and a screwdriver. In order to avoid the implant in the bone being exposed to the tightening torque, a counter torque wrench must always be used when tightening the connection screw. Any debris that may have formed around or inside the abutment should be removed. If there are signs of skin irritation or infection a mild antibiotic cream/ointment should be applied. 6 weeks after fitting Ponto Subjective evaluation it is recommended to let the patient fill in a questionnaire and thereby measure the benefit and satisfaction with the sound processor. Objective evaluation it is recommended to measure the patient s word recognition score in noise. The aided free field measurements will indicate the client s aided threshold. 6 months after fitting Ponto Both objective and subjective evaluations may be performed when the patient is acclimatized to the sound processor. Objective evaluation Free field aided audiometry Word recognition score in noise Both tests are performed in a free sound field. The tests may be conducted under three different conditions unaided, aided with the sound processor and aided with the previous hearing solution/situation. The volume control should be set to the most comfortable level (MCL) on each device. Subjective evaluation It is recommended that a subjective questionnaire is filled in by the patient after a minimum of six months from the fitting of the sound processor. The questionnaire may be filled in either during a follow-up visit or at home. Every 6 months Check the abutment and surrounding skin. Check the overall performance of the sound processor. Usually a follow-up visit twice a year will be sufficient to ensure proper maintenance, but some patients may require more frequent following-up. Evaluate the need for accessories. Assess whether the patient is managing the daily cleaning of the skin. Check the abutment and surrounding skin. 17

18 Important patient information It is important to follow the skin hygiene guidelines; the patient should contact the clinic if he or she has questions or concerns. The sound processor should always be kept in its box when it is not being worn to protect it from dust and dirt. Whenever the sound processor is not in use for longer periods (i.e. more than 5 hours), the patient should switch it off by opening the battery door. The battery door should be left open so that any moisture in the sound processor is allowed to dry. When using a telephone, the receiver of the telephone is held close to the sound processor. To avoid feedback (whistling sound) the telephone must not touch the sound processor. The sound processor shall be removed or the safety line used when taking part in activities where there is a risk that the sound processor may fall off. The sound processor must be covered when applying hair products. To avoid setting off metal detectors when traveling, the sound processor can be removed before passing through the security controls. Electronic items should be disposed of in accordance with local regulation. Warning! The test band, head band or soft band must not be placed on top of an abutment or bone anchored implant. The test band, head band and soft band contains small parts that may constitute a choking hazard for children or persons of diminished mental capacity, and should not be used by such individuals without adult supervision. Parents or caregivers should always check the soft band before use to ensure that the connection disc is properly attached and that the sound processor is functioning properly. Common problems and their solutions Symptom Possible causes Solutions No sound Intermittent or reduced sound Whistling noise Worn-out battery Sound processor is in stand-by mode (mute) Dirt in the coupling or sound inlet Moisture Worn-out battery Sound processor touches something Change battery Press push button Clean the sound processor Open the battery drawer and let the sound processor dry out in its case Change battery Check that the sound processor is correctly connected and is not touching anything. Run the Feedback Manager in Genie Medical 18 Consider whether the abutment should be changed to a longer or an angled abutment

19 Warning! The sound processor, batteries, parts and accessories are not toys and should be kept out of reach of children and anyone who might swallow these items or otherwise cause injury to themselves. The sound processor contains small parts that may be a choking hazard for small children. Never dispose of your sound processor, its parts or batteries by burning them. There is a risk that they will explode and cause serious injury. The sound processor is not waterproof! Always disconnect the sound processor before showering or bathing/swimming. If the sound processor accidentally gets wet, open the battery door and take out the battery to let the sound processor dry. Avoid exposing the sound processor to extreme heat. Disconnect the sound processor if you need to undergo MRI (Magnetic Resonance Imaging)! The implant and the abutment can remain in place. Battery use Always use batteries recommended by your hearing care professional. Batteries of low quality may leak and cause bodily harm. Safety requirements regarding Direct Audio Input (DAI) An audio adapter with an isolation transformer, that fulfills medical safety isolation (i.e., according to IEC ), shall always be used when connecting to any equipment having a power supply or battery with a voltage higher than 12 V. Direct connection of any equipment with an electrical supply of higher than 12 V is potentially dangerous and may prove fatal. When an isolated audio adapter is connected to mains-operated equipment, this equipment must comply with electrical safety standards for consumer products (i.e. IEC or equivalent safety standards). Dysfunction in sound processors The sound processor may stop functioning, for instance if the batteries have expired. You should be aware of this possibility, in particular when you are in traffic or otherwise dependent on warning sounds. Possible side effects The otherwise non-allergenic materials used in sound processors may in rare cases cause a skin irritation. Consult a doctor if you experience any side effects. Batteries can be harmful if swallowed. Always keep batteries out of reach of small children or people of diminished mental capacity. If a battery is accidentally swallowed, seek medical attention at the nearest emergency department! 19

20 Factory settings Factory setting features for Ponto Pro and Ponto Pro Power models Program Beeps Type Function 1 General microphone Wide band amplification, automatic directionality, noise reduction 2 General microphone High frequency emphasis, automatic directionality, noise reduction 3 External audio input Microphones off, signal input from DAI connector Factory setting for Ponto model Program Beeps Type Function 1 General microphone Wide band amplification, omni-directional 2 General microphone High frequency emphasis due to full directionality 3 External audio input Microphones off, signal input from DAI connector The beeps indicated in the table are the number of beeps that are presented when changing to a specific program. Although the Genie Medical software allows for individual fittings, Ponto, Ponto Pro and Ponto Pro Power are delivered with a factory setup that can be useful in clinical situations when the Genie Medical software might not be available or if the time set aside for the preoperative fitting is limited. The factory setting has three programs, two different microphone listening programs and one program for listening via the direct audio input connector. The two different microphone listening programs (P1 and P2) are designed for different hearing loss slopes: P1 for flat BC hearing losses and P2 for sloping BC hearing losses and single-sided deafness patients. The patient should increase / decrease the volume control to find the appropriate gain level. 20

21 Feature overview Features Ponto Ponto Pro Ponto Pro Power Sound processing features 15 sound processing channels Multiband Adaptive Directionality Manual Automatic Automatic Tri-state Noise Reduction Wind Noise Reduction Dynamic Feedback Cancellation Output AGC Speech Guard Battery management system Fitting features Fitting software, Genie Medical 10-channel frequency response shaping BC In-situ Audiometry Feedback Manager Data Logging Learning Volume Control The physical product and operation aspects Up to 4 programs Volume control Start-up delay Mute/stand-by function Low battery warning Tamper-resistant battery door Telecoil/DAI/FM input Nano coating Color Palette White Silver Chroma Beige Mocca Brown Diamond Black White Silver Chroma Beige Mocca Brown Diamond Black White Silver Chroma Beige Mocca Brown Diamond Black 21

22 Description of advanced features available in all Ponto sound processors Wind Noise Reduction Depending on the wind noise level, sounds will be attenuated. The more wind, the more attenuation. In Ponto Pro and Ponto Pro Power the Wind Noise Reduction system will in addition force the instrument into Omni directionality mode. Feedback Management System The Feedback Management System consists of two parts: Feedback Manager and Dynamic Feedback Cancellation. The Feedback Manager is a tool in Genie Medical that measures and applies feedback limits in the sound processor. The feedback limits are set to prevent static feedback and to facilitate the full use of the entire range of the volume control without feedback. Dynamic Feedback Cancellation (DFC) is a feature in the sound processor that constantly checks for the presence of acoustic feedback. When feedback is detected, the DFC system phase cancels the feedback signal. DFC is designed to minimize the risk of feedback by adapting to sudden acoustical changes. Automatic Gain Control All Ponto sound processors have an Automatic Gain Control that adjusts the gain to the environment. The Automatic Gain Control can work both over the whole frequency range and in each of the 10 frequency bands. There is an output AGC that ensures there is no distorted peak clipped signal at saturation level of the instrument.a peak clipped signal distorts the sinus signal. By avoiding this distortion, increased sound comfort is achieved. Speech Guard Speech Guard is a signal processing system that works by maintaining linear processing as much as possible, but at the same time responding instantaneously to rapidly occurring environmental sounds Speech Guard is designed to produce less distortion than traditional compression systems. BC In-situ Audiometry BC In-situ Audiometry is a tool in Genie Medical for measuring the patient s bone conduction hearing thresholds directly via the sound processor. Description of advanced features available in Ponto Pro and Ponto Pro Power Automatic Multiband Adaptive Directionality The system analyzes information from various environmental detectors and automatically chooses one of the three different directionality modes with the aim of automatically offering an improved speech to noise ratio in adverse listening situations. The directionality modes are Omni, Split Directionality and Full Directionality. Tri-state Noise Reduction The Tri-state Noise Reduction system continuously analyzes the environment and aims at providing the appropriate amount of attenuation in different listening environments. It includes the detection of speech, environmental background noise and wind noise. The system automatically moves seamlessly between the different states. The aim of this system is to provide some degree of comfort in noisy environments while preserving the information most important for speech intelligibility. Data Logging Data Logging permits Ponto Pro and Ponto Pro Power to memorize listening levels, usage time, user settings and system states. The data can be analyzed externally, providing the audiologist and the patient with valuable information. The Information can be used to adjust the system settings in order to optimize patient comfort and speech intelligibility in any complex listening situation. 22

23 Learning Volume Control The Learning Volume Control enables the hearing system to adjust automatically to patient preferences over time. Different listening situations and preferred volume settings are memorized. The system continuously analyzes listening situations and automatically adjusts the volume to the memorized preferred setting. In this way the system assist to get the preferred volume for the patient without his/hers manual adjustment of the volume control. References 1. Mylanus EA, van der Pouw KC, Snik AF, Cremers CW. Intraindividual comparison of the bone-anchored hearing aid and air-conduction hearing aids. Archives of Otolaryngology-Head & Neck Surgery 1998;124(3): Wazen JJ, Spitzer JB, Ghossaini SN, Fayad JN, Niparko JK, et al. Transcranial contralateral cochlear stimulation in unilateral deafness.otolaryngology-head & Neck Surgery 2003;129(3): Bosman AJ, Snik AF, van der Pouw CT, Mylanus EA, Cremers CW. Audiometric evaluation of bilaterally fitted bone-anchored hearing aids. Audiology 2001 May-June;40(3): Snik AF, Mylanus EA, Proops DW, Wolfaardt JF, Hodgetts WE, Somers T, Niparko JK, Wazen JJ, Sterkers O, Cremers CW, Tjellström A.Consensus statement on the Baha system: where do we stand at present? The Annals of otology, rhinology & laryngology 2005 Dec;114(195): Tjellström A, Håkansson B, Granström G. Bone-anchored hearing aids: current status in adults and children. Otolaryngologic Clinics of North America 2001 Apr;34(2): Departments of Otolaryngology, and Audiology, University Hospital NHS Trust Birmingham. The Birmingham Bone Anchored Hearing Aid Program The Journal of Laryngology & Otology 1996: Vol. 110, Supplement 21. Products that can be used with the Ponto system Ponto System component Ponto, Ponto Pro and Ponto Pro Power sound processors , , , , , , , , , , , , , , , , , , , , M50676, M50677, M50872, M50873, M50874, M70875, M50881, M50883, M50884, M50902, M50903 Implants with premounted abutments (M50358, M50784, M50785) Abutments (M50318, M50349, M50362) Products with ref. no manufactured by Cochlear Bone Anchored Solutions AB Baha abutment (90305, 90410) Baha implants with abutment (90434, 90480) Baha audio adapter (90065) Baha telecoil unit (90185) Baha sound processors with snap coupling; Baha Divino (90500, 90510, 90501, 90511, 90502, 90512, 90503, 90513) Baha Intenso (90730, 90731, 90732, 90733) Baha Cordelle (HCB 400-0, HCB 401-0, HCB 402-0) Baha BP100 (91300, 91301, 91302, 91303, 91304, 91305) Oticon Medical Ponto series sound processors and abutments used together with the above listed sound processors and abutments from Cochlear Bone Anchored Solutions AB secures similar sound transmission, connection force and disconnection force. The sound quality and experience is determined by the sound processor that is being used. 23

24 Manufacturer: Oticon Medical AB Ekonomivägen 2 SE Askim Sweden Regional office: Oticon Medical, LLC 19 Schoolhouse Road Somerset, NJ USA Phone: info@oticonmedical.com Phone: info@oticonmedicalusa.com M51019 /