Middle Ear Implants. Indications and Techniques. T. Lenarz. Age and Hearing, Hamburg Germany October 2011

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1 Middle Ear Implants Indications and Techniques T. Lenarz Age and Hearing, Hamburg Germany October 11 Dept Otolaryngology, Medical University Hannover, Germany (Chairman: Thomas Lenarz, MD PhD)

2 Hearing Devices Acoustical Stimulation Conventional Hearing Aid Electrical Stimulation CI ABI AMI Mechanical Stimulation Implantable Hearing Aid Electroacoustical Stimulation Semi imp. Fully imp. Hybrid / EAS

3 Implantable Hearing Aids Semi impl. HA Fully impl. HA passive hearing systems Cochlear BAHA Active hearing systems MEDÉL Vibrant Soundbridge Active hearing systems Otologics CARINA AURIC Retro-X Otologics MET DACS Envoy Esteem Lyric by Schindler/Phonak

4 Middle Ear Implants s Implantable Hearing Aids Devices Indications Results Place in the field Future potential

5 BAHA = Bone Anchored Hearing Aid

6 Indications for BAHA Malformations of outer and middle ear Middle ear related conductive or combined hearing loss which cannot be improved by ear surgery Post surgical conditions Conductive or mixed hearing loss (avbc < 3 db)

7 Chronic Otitis media Frequency [khz] R,125,25,5 1 1, Hearing Loss [db HL] BC unaided AC unaided

8 Chronic Otitis media Frequency [khz] R,125,25,5 1 1, Hearing Loss [db HL] BC unaided AC unaided AC free field (aided with BAHA)

9 Single Sided Deafness (SSD) better sound source localization? better speech in noise intelligibility

10 Bonebridge System: transcutaneous active bone anchored hearing aid

11 BB Patient DS, a 28 year-old male Caucasian patient. s/p Tympanoplasty, Type IIIa approximately 14 years previously

12 BB Implantation Surgery The implant is then placed into position and secured using screws to a specific torque.

13 Bonebridge Pat. 2: 1 day postop

14 Vibrant Soundbridge [VSB] Frequenz in khz,125,25,5 1 1, Hörverlust in db HL BC FMT

15 VSB Coupling: VIBROPLASTY Vibrant classic Vibrant round window Vibrant TORP Vibrant PORP Vibrant Piston Vibrant?

16 Vibrant Soundbridge MHH experience Implantations since Incus 123 Bilateral Incus 17 Round Window (incl. RW-Coupler) 62 RW-Coupler only Bilateral RW 5 Power-Stapes 19 Bilateral PS 2 Vibrant PORP (Stapes head) 7 Bilateral VP 1 Oval Window 3 Bilateral Incus/RW 1

17 Incus Air- / Bone conduction AC pre-/ postoperative Incus, N = 121 BC pre-/ postoperative Incus, N = 121 Hearing Level in db (HL) Frequency in Hz k 1.5k2k 3k 4k 6k 8k Hearing Level in db (HL) Frequency in Hz k 1.5k2k 3k 4k 6k 8k preop postop preop postop

18 Incus unaided / aided 35 Functional Gain for application Incus, N=111 Freefield audiometry with pure tones Incus, N = 111 Hearing Level in db (HL) Frequency in Hz k 1.5k2k 3k 4k 6k 8k Frequency in Hz 1 Freefield speech discrimination with Freiburger monosyllabic Test Incus, N=11 Hearing Level in db (HL) unaided aided Speech discrimination in % ,5 17,8 75,8 5, 65 8 N = 61 N = 95 db SPL unaided VSB

19 Round Window Air- / Bone conduction (incl. RW-Coupler) AC pre- and postoperative with pure tones for application Round Window, N = 53 BC pre- and postoperative with pure tones for application Round Window, N = 53-1 Frequency in Hz k 1.5k2k 3k 4k 6k 8k -1 Frequency in Hz k 1.5k 2k 3k 4k 6k 8k 1 1 Hearing Level in db (HL) Hearing Level in db (HL) preop postop preop postop

20 Round Window unaided / aided Functional Gain for application Round Window, N = Freefield audiometry with pure tones for application Round Window, N = 38 Frequency in Hz k 1.5k2k 3k 4k 6k 8k Hearing Level in db (HL) Frequency in Hz Hearing Level in db (HL) unaided VSB BC postop Speech discrimination in % Freefield speech discrimination with Freiburger monosyllabic test Round Window, N = 38 66,84 1, 82,11 14, db SPL unaided VSB

21 Otologics MET and CARINA Hearing Loss [db HL],125,25,5 1 1, Frequency [khz]

22 Pure Tone Audiometry Frequency [khz] AC pre op AC post op db HL n= 44, post op Ø 2,1 years

23 Functional Gain by MET Frequency [khz] FF unaided FF aided with MET db HL n= 44, post op Ø 2,8 years

24 Speech performance HA vs MET 1 8 ohne mit HG mit MET 65 8 n= 44, post op Ø 2,8 years

25 Free Field Audiometry with CARINA (fully implantable system) Frequenz khz,25,5 1 1, db SPL unaided CARINA 8 1 n = 6

26 Speech Discrimination with CARINA 1 8 % unaided CARINA HA 65 8 db SPL

27 C-DACS Concept (frequency transfer function adapted to that of human middle and inner ear,; MPO 142 db HL

28 C-DACS Concept (frequency transfer function adapted to that of human middle and inner ear,; MPO 142 db HL DACS Indications Profound mixed hearing loss with an irreparable conductive component (Advanced) Otosclerosis Chronic otitis media Tumors Severe hearing loss unable to wear hearing aid Earmould incompatibility or allergy Atresia, stenosis

29 Cochlear DACS-ID (Direct Acoustic Cochlear Stimulator Investigation Device) Freedom Sound Processor with DACS Signal Processing C-DACS ID Clinical Trial at MHH n = 15 Mixed severe to profound hearing loss due to otosclerosis BC-Threshold > 3dB ABG 3dB at least at 3 freqencies

30 Pure Tone Audiometry (PTA) db [HL] Audiometric Frequency [Hz] k 1.5k 2k 3k 4k 6k 8k p =.16 AC pre op BC pre op BC 2-4 month post op AC 2-4 month post op n = 1 Bars show minimum and maximum values.

31 Free Field Audiometry db [HL] Audiometric Frequency [Hz] k 1.5k 2k 3k 4k 6k 8k free field unaided pre-op free field unaided (3 month post activ.) best aided HA best aided C-DACS (3 month post activ.) n = 8 Bars show minimum and maximum values.

32 Speech Discrimination Score (SDS) 1 unaided HA C-DACS 8 % correct NA NA NA Pat.1 Pat.2 Pat.3 Pat.4 Pat. 5 Pat. 6 Pat. 7 Pat. 8 Mean SDS Freiburg monosyllabic test at 65 db Bars show minimum and maximum values.

33 Speech in noise (OLSA) -4-2 Pat. 1 Pat. 2 Pat. 3 Pat. 4 Pat. 5 Pat. 6 Pat. 7 Pat. 8 mean SNR better SNR 5% [db] NA NA NA 1 12 HA 14 C-DACS (3 month post activation) Bars show minimum and maximum values.

34 Indication for hearing devices for CHL & MHL ABG db HL AC db HL 8 1 1

35 Indication for hearing devices for CHL & MHL AC db HL conv. HA ABG db HL 8 1 1

36 Indication for hearing devices for CHL & MHL AC db HL conv. HA ABG db HL 8 1 CI CI 1

37 Indication for hearing devices for CHL & MHL BAHA AC db HL conv. HA ABG db HL imp. HA 8 VSB-RW 1 CI CI 1 DACS

38 Cochlear Implant low high Electrode Auditory Nerve

39 Electrode Design for Hearing Preservation Cochlear Implantation.5 mm.3 mm 16 mm Contour Advance Hybrid-L

40 Hybrid System for Electro-Acoustic Hearing db (HL) Audiometric Frequency [Hz] k 1.5k 2k 3k 4k 6k 8k ~1 Hz - 1 Hz Pre OP

41 Hybrid System for Electro-Acoustic Hearing db (HL) Audiometric Frequency [Hz] k 1.5k 2k 3k 4k 6k 8k acoustic amplification ~1 Hz - 1 Hz Pre OP electrical stimulation with cochlear implant ~1 Hz - 8 Hz

42 Hybrid-L24 Patients at MHH (n = 132) PTA pre- and postoperative Initial Activation N = months post OP N = 55 db (HL) Audiometric Frequency [Hz] k 1.5k 2k 3k 4k 6k 8k db (HL) Audiometric Frequency [Hz] k 1.5k 2k 3k 4k 6k 8k pre OP post OP (Init fitting) Post OP - pre OP pre OP post OP (9 Mo) Post OP - pre OP Median loss Hz : 1 db Median loss Hz : 1 db

43 OLSA adaptive in noise pre op with Hearing Aid vs. 6 months post op with Hybrid Individual speech data (S1 to S28) Median (N=28)

44 Indications for Hearing Devices Hearing Aids kon. HG

45 Indications for Hearing Devices BAHA Hearing Aids VSB Imp. HG kon. HG CARINA Esteem

46 Indications for Hearing Devices BAHA Hearing Aids VSB Imp. HG kon. HG CARINA CI CI Esteem

47 Indications for Hearing Devices BAHA Hearing Aids VSB Imp. HG kon. HG CARINA Hybrid CI 1 CI 22 Esteem Hybrid EAS

48 Indications for Implantable Hearing Aids Conductive loss which cannot be improved surgically Sensory hearing loss: moderate to severe Medical: recurrent or chronic external otitis, others Audiological: not satisfactory hearing improvement with conventional hearing aids Mixed loss

49 Implantable Hearing Aids Indications for conductive, mixed or sensorineural hearing loss Improvement in hearing superior to conventional hearing aids Selection of device based on type and degree of hearing loss Hybrid systems for electro-mechanical stimulation Fully implantable systems are not recommended at present due to technical limitations

50 Thank you MHH Hannover Ear Institute

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