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OTOlogics
Carina the fully implantable
hearing solution

Dr. Dr. h.c. Monika Lehnhardt


                Yerevan , September 4, 2009
OTOlogics
Established in 1996 in Boulder, Colorado
Our focus is on middle ear implants (MEI)
Products:
    Carina      fully implantable
    MET       semi-implantable hearing system
Implanted in more than 80 clinics worldwide
+ 800 patients benefit from Otologics technology
The Fully Implantable Hearing System



   Carina
CE mark for SNHL Oct. 2006



CE mark for CMHL in 2007
Carina
       The fully implantable hearing system


                                  Microphone
Communication
    coil
                                     Rechargeable battery

   Transducer                        Digital
                                     signal-processor
Carina             Accessories




Charging station
- On / Off
- Louder/Softer    Remote:
                   - On / Off
                   - Louder/Softer
Battery Life
Battery Service Life profile from accelerated life test data. Assumes complete
discharge, 50 mAh battery and an implantable middle ear hearing device
Location of the microphone



             Mounting plate   Transducer




                                 Capsule
             Microphone
Sensorineural Hearing Loss

Patients with a normal middle ear anatomy
And with a mobile ossicular chain
Transducer simply placed in contact with the incus
Audiological Guidelines
Hearing loss, preferably not exceeding 70dB HL
Pure tone air and bone conductions must be within this range
Preserved speech discrimination
Experience in using hearing aids is preferable
Indications

For patients with

 Ear canal complications (size, allergies, reactions )
 Hearing aid users with dermatitis, psoriasis,
  chronic external otitis
 And those working in challenging environments
 (water, dust)
 Removes the stigma of wearing an external device
Conductive Hearing Loss
Flexible placement options of the transducer
Delivers clear and powerful acoustic signals to the cochlea




     Stapes          Round Window         Oval Window
Indications

 Congenital Aural Atresia

 Healed Cholesteatoma

 Revised Ossiculoplasties

 Traumatic Injury

Counter indications:
- Persistent middle ear infections
- Tympanic perforation
Mixed Hearing Loss
Audiological guidelines:

 SNHL preferably not exceeding 70dB HL
 Preserved speech discrimination scores

Indications:
  Otosclerosis
  Healed cholesteatoma with a sensorineural component
  Stabilized chronic otitis media with a sensorineural
  component
  Cases of conductive hearing loss with a growing
  deterioration of sensorineural hearing
Conclusions

 MET and Carina cover a broad range of the hearing loss
 Safe surgeries - no risk - fully reversible
 Very stable implanting systems

 Carina:
ü indicated for multiple hearing loss profiles
ü many options for middle ear stimulation
ü an invisible hearing system
ü a unique alternative for
       severe mixed hearing loss
          working in challenging conditions
c

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Carina fully implantable hearing solution overview

  • 1. OTOlogics Carina the fully implantable hearing solution Dr. Dr. h.c. Monika Lehnhardt Yerevan , September 4, 2009
  • 2. OTOlogics Established in 1996 in Boulder, Colorado Our focus is on middle ear implants (MEI) Products: Carina fully implantable MET semi-implantable hearing system Implanted in more than 80 clinics worldwide + 800 patients benefit from Otologics technology
  • 3. The Fully Implantable Hearing System Carina CE mark for SNHL Oct. 2006 CE mark for CMHL in 2007
  • 4. Carina The fully implantable hearing system Microphone Communication coil Rechargeable battery Transducer Digital signal-processor
  • 5. Carina Accessories Charging station - On / Off - Louder/Softer Remote: - On / Off - Louder/Softer
  • 6. Battery Life Battery Service Life profile from accelerated life test data. Assumes complete discharge, 50 mAh battery and an implantable middle ear hearing device
  • 7. Location of the microphone Mounting plate Transducer Capsule Microphone
  • 8. Sensorineural Hearing Loss Patients with a normal middle ear anatomy And with a mobile ossicular chain Transducer simply placed in contact with the incus
  • 9. Audiological Guidelines Hearing loss, preferably not exceeding 70dB HL Pure tone air and bone conductions must be within this range Preserved speech discrimination Experience in using hearing aids is preferable
  • 10. Indications For patients with Ear canal complications (size, allergies, reactions ) Hearing aid users with dermatitis, psoriasis, chronic external otitis And those working in challenging environments (water, dust) Removes the stigma of wearing an external device
  • 11. Conductive Hearing Loss Flexible placement options of the transducer Delivers clear and powerful acoustic signals to the cochlea Stapes Round Window Oval Window
  • 12. Indications Congenital Aural Atresia Healed Cholesteatoma Revised Ossiculoplasties Traumatic Injury Counter indications: - Persistent middle ear infections - Tympanic perforation
  • 13. Mixed Hearing Loss Audiological guidelines: SNHL preferably not exceeding 70dB HL Preserved speech discrimination scores Indications: Otosclerosis Healed cholesteatoma with a sensorineural component Stabilized chronic otitis media with a sensorineural component Cases of conductive hearing loss with a growing deterioration of sensorineural hearing
  • 14. Conclusions MET and Carina cover a broad range of the hearing loss Safe surgeries - no risk - fully reversible Very stable implanting systems Carina: ü indicated for multiple hearing loss profiles ü many options for middle ear stimulation ü an invisible hearing system ü a unique alternative for severe mixed hearing loss working in challenging conditions
  • 15. c