Clinical experience with Audera

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Implanterbare høreapparater 10 februar
2005 Sten Harris
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Sten Harris ? Ørekirurg Audiolog Otoaudiologisk
seksjon RH
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Implanterbare høreapparater ? Semi-implantable
hearing aids Totally implantable hearing aids (
BAHA, CI)
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Varför implantera hörapp? Kombination av
problem/missnöje med konventionell HA och nya
tekniska möjligheter
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Problem konventionell HA
Begränsad frekvensgång Dålig ljudkvalitet Hörappar
atproppen ocklusion,infektion,allergi Tål ej
vatten Kosmetik/fåfänga
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mikr
HA
hörtelefon
förstärkare
Implanterb HA mekanisk stimulering
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Implantabla hörapparater?

• God ljudkvalitet
• Bred frekvensgång
• Mindre återkoppling

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Semi- implantabla hörapparater
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Historik

• Piezoelektriska system
• Vernon 1972
• Suzuki-Yanagihara

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Piezoelektriskt System RION
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Historik

• Elektromagnetiska system
• Fredrickson 1973

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Elektromagnetiskt system
Richards
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Elektromagnetiskt system Soundtec

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Semi-implantabla HA idag
Vibrant--MED-EL MET--Otologics
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symphonix
Vibrant Soundbridge
MED-EL
Audio Processor
Receiver (VORP)
Conductor lead
FMT Floating Mass Transducer
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External Part Audio Processor
The external part contains the microphone,
battery, a Digital signal processor (Signia /
Siemens) and a RF modulator. 2.5 Cm in
diameter. Held in place over the implant with
a magnet.
3 Colors Brown, Beige, Grey
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Audio Processor in Place

• no occlusion (ear canal free)
• easily hidden (covered by hair)
• Held by magnetic attraction

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Vibrating Ossicular Prosthesis (VORP)
Demodulator
Magnet
Receiver coil
Silicone
Floating Mass Transducer
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FMT Floating Mass Transducer
The Floating Mass TM is attached to the long
process of the incus with a Titanium clip
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Position of the FMT
Left Ear
The FMT should be in close contact and parallel
to the stapes
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Vibrant Soundbridge Middle Ear Implant
April 2003
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Geoff Ball
The inventor of the Vibrant Soundbridge is
himself implanted (bilaterally)
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Vibrant Soundbridge Selection Criteria

• Word recognition score of 50 or better - to
  assess the cochlear integrity
• Normal middle ear anatomy and sensorineural
  hearing loss - so as not to impede the energy
  transfer or the ossicular movement
• Realistic expectations of the benefits and
  limitations of the device

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MET Ossicular Stimulator
OTOLOGICS

• Electromechanical transducer
• Direct coupling to incus by advancing transducer
  probe tip into laser made hole within body of
  incus
• Fibrous union formed during healing period
• Peak Output 118 dB, Frequency range lt200 to
  6250 Hz
• No disarticulation of Ossicles
• Nothing in ear canal

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Otologics Semi-Implantable Technology

MET Ossicular Stimulator

Button Audio Processor
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Incision
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Atticotomy
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Fastening the Mounting Bracket
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Transducer Placement
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Securing the Electronics
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Patient Selection Criteria

• Adults with sensorineural (cochlear) hearing loss
• Post-lingual onset of hearing loss
• No signs or symptoms of conductive, mixed,
  retrocochlear, central auditory, or functional
  hearing loss
• Stable hearing loss
• No medical contraindications to surgery or middle
  ear implantation
• Realistic expectations of device benefit

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Thresholds
Bone Conduction
Air Conduction
N112
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• RH-erfarenheter- Otologics
• Kvinna f 57
• Sensorineural hns 40 dB
• Missnöjd HA ssk ocklusionseffekt
• Mycket nöjd efter op-
• men tekniskt breakdown efter ett år
• ej bättre efter reop

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RH-erfarenheter- Otologics 2. Man f 49 komb
hns- cochleär hudsjukdom. PTA 30/50 Klarar ej
HA el BAHA. Efter en hel del programmerings- beky
mmer nu en mycket belåten bärare Åter i yrkeslivet
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Pas 3.
Kvinna f.1962 Progressiv hns Kan ej ha propp Op
aug 03 vä Önskar op hö
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Helt implanterade hörapparater
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Implex det første helt implanterte hørepparatet
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OTOLOGICS
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Implant
Microphone
Digital Signal Processor
Battery
IS-1 Connector
Lead
Receiver Coil
Magnet
Transducer
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Upgrade Surgical Procedure
Semi-Implantable
Fully-Implantable
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MET Fully-Implantable System
Implant
Remote
Charging System
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Charging

• Implant Charger
• Recharges battery of implant
• Daily recharge takes less than 1 hour
• Patient can use implant during re-charge
• Base Station
• Charges implant charger
• Implant Battery
• Warranted for 5 years
• Life gt 12 years

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Remote

• Volume control
• On/Off

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Programming System

• NOAHlink System
• Fitting System
• Diagnostic System

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FIMOS FDA Clinical Trial

• Implants to start Q1 2005
• US
• IDE Approval to begin recruiting patients
• 20 patients from up to 15 centers
• EU
• 25 Patients from 7-10 sites

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Tack för uppmärksamheten