Implantable Treatments for Different Types of Hearing Loss. Margaret Dillon, AuD Marcia Adunka, AuD
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1 Implantable Treatments for Different Types of Hearing Loss Margaret Dillon, AuD Marcia Adunka, AuD
2 Implantable Technologies Types of hearing loss Bone-anchored devices Middle ear implantation Cochlear implantation
3 Audiogram Normal Mild Moderate Severe Profound
4 Audiogram Normal Mild Moderate Severe Profound
5 Audiogram Normal Mild Moderate Severe Profound
6 Types of Hearing Loss Conductive» Dysfunction in the conduction of sound by the outer ear, tympanic membrane, and/or middle ear Sensorineural» Dysfunction within the inner ear (cochlea) and/or auditory nerve Mixed» Conductive + Sensorineural
7 Types of Hearing Loss Conductive» Dysfunction in the conduction of sound by the outer ear, tympanic membrane, and/or middle ear MED-EL Corporation
8 Types of Hearing Loss: Conductive
9 Types of Hearing Loss Sensorineural» Dysfunction within the inner ear (cochlea) and/or auditory nerve MED-EL Corporation
10 Types of Hearing Loss: Sensorineural
11 Types of Hearing Loss Mixed» Conductive + Sensorineural MED-EL Corporation
12 Types of Hearing Loss: Mixed
13 Hearing Aids Amplify the acoustic signal Phonak
14 Implantable Treatments Bone-anchored devices» Transmission of sound via bone conduction Middle ear implants» Transmission of sound via vibratory stimulation Cochlear implants» Transmission of sound via electric stimulation of the auditory nerve
15 Bone-Anchored Devices Stimulation of the acoustic signal via bone conduction
16 Bone-Anchored Devices Three Part System:» Titanium Screw surgically implanted into mastoid Approximately 2 month osseointegration» External Abutment transfers the sound vibrations» Sound Processor Cochlear Corporation
17 Bone-Anchored Devices Indications (FDA approvals)» CHL and Mixed HL (1996)» Single-Sided Deafness (SSD; 2002) Oticon
18 Middle Ear Implants Esteem» Envoy Medical Maxum» Ototronix Vibrant Soundbridge (VSB)» MED-EL Corporation
19 Vibrant Soundbridge (VSB) Converts sound into controlled, amplified vibrations Direct drive stimulation of the middle ear structures MED-EL Corporation
20 Vibrant Soundbridge (VSB) Two Part System:» Internal Vibrating Ossicular Prosthesis (VORP) MED-EL Corporation
21 Vibrant Soundbridge (VSB) Vibrating Ossicular Prosthesis (VORP) with Floating Mass Transducer (FMT)» Wide frequency range up to 8 khz» Preservation of residual hearing MED-EL Corporation
22 Vibrant Soundbridge (VSB) MED-EL Corporation
23 Vibrant Soundbridge (VSB) Two Part System:» External Audio Processor MED-EL Corporation
24 Vibrant Soundbridge (VSB) Magnetic connection between internal and external components MED-EL Corporation
25 Vibrant Soundbridge (VSB) Approved Indications» Adults» Bilateral moderate-to-severe sensorineural hearing loss» Word Rec > 50% MED-EL Corporation
26 VSB Clinical Trial Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Loss, Using Direct Round Window Cochlear Stimulation» Multi-center clinical trial to evaluate VSB in a new population» Sponsored MED-EL Corporation CAUTION: Investigational device. Limited by US law to investigational use.
27 VSB Clinical Trial Candidacy Criteria» Conductive & mixed hearing loss» Traditional amplification unsuccessful» Word Rec > 30% CNC Words CAUTION: Investigational device. Limited by US law to investigational use.
28 VSB Clinical Trial Candidacy Criteria» Conductive & mixed hearing loss 4/26/ CAUTION: Investigational device. Limited by US law to investigational use.
29 VSB Clinical Trial MED-EL Corporation CAUTION: Investigational device. Limited by US law to investigational use.
30 VSB Clinical Trial Potential Conditions» Congenital malformations (Atresia, Microtia)» Stenosis of external auditory canal» Allergies to earmold material» Chronic otitis externa» Chronic draining ears» Eczema/Psoriasis of the ear» Unresolved acoustic feedback» Large mastoid bowl following surgery CAUTION: Investigational device. Limited by US law to investigational use.
31 VSB Clinical Trial FMT placed in Round Window (RW) Niche» Bypass conductive component to deliver vibrations directly to the cochlea» Active RW stimulation MED-EL Corporation CAUTION: Investigational device. Limited by US law to investigational use.
32 VSB Clinical Trial Potential Benefits» Appropriate amplification» Little to no acoustic feedback» Improved ability to understand speech in quiet and noise» Ability to wear technology without occluding the ear canal CAUTION: Investigational device. Limited by US law to investigational use.
33 VSB Clinical Trial Results CAUTION: Investigational device. Limited by US law to investigational use.
34 Cochlear Implantation Electrical representation of an acoustic signal» Insertion into scala tympani of the cochlea» Bypass damaged sensory cells 4/26/ MED-EL Corporation; Advanced MED-EL Bionics Corporation
35 Cochlear Implantation Cochlear Corporation
36 Cochlear Implantation Indications» Moderate-to-profound sensorineural hearing loss» Limited speech perception abilities with conventional amplification. Pre-Operative Aided Speech Testing Word Test Hearing Aid: 16% A B = Hearing Aid Both Ears 4/26/ MED-EL Corporation
37 Cochlear Implantation Post-operative Post-Operative Aided Speech Testing Word Test CI Right 80% CI Left 84% C R = Cochlear Implant Right Ear C L = Cochlear Implant Left Ear
38 Cochlear Implantation Cochlear Implant Candidate?» Greater residual low-frequency hearing, yet poor speech perception Pre-Operative Aided Speech Testing Word Test Hearing Aid: 26% A L = Hearing Aid Left Ear CAUTION: Investigational device. Limited by US law to investigational use.
39 Electric-Acoustic Stimulation CAUTION: Investigational device. Limited by US law to investigational use.
40 Electric-Acoustic Stimulation Candidacy criteria CAUTION: Investigational device. Limited by US law to investigational use.
41 Electric-Acoustic Stimulation Candidacy Criteria» Adults (>18 years)» Stable hearing thresholds» Poor speech perception with appropriately fit hearing aids CAUTION: Investigational device. Limited by US law to investigational use.
42 Electric-Acoustic Stimulation Results CAUTION: Investigational device. Limited by US law to investigational use.
43 Electric-Acoustic Stimulation Preoperative Pre-Operative Aided Speech Testing Word Test Hearing Aid: 26% A L = Hearing Aid Left Ear CAUTION: Investigational device. Limited by US law to investigational use.
44 Electric-Acoustic Stimulation Post-operative Post-Operative Aided Speech Testing Word Test EAS 90% C L = Cochlear Implant Left Ear 4/26/ CAUTION: Investigational device. Limited by US law to investigational use.
45 Contact Margaret Dillon, AuD, CCC-A, F-AAA Assistant Professor University of North Carolina at Chapel Hill School of Medicine Department of Otolaryngology / Head and Neck Surgery mdillon@med.unc.edu 4/26/
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