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Middle Ear Implants: An Overview

Middle Ear Implants: An Overview. Jonathan H. Spindel, Ph.D. Sensory-Neural Engineering Research Laboratory. College of Integrated Science and Technology James Madison University, Harrisonburg, Virginia http://sharepoint.cisat.jmu.edu/isat/spindejh/presentations e-mail: spindejh@jmu.edu.

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Middle Ear Implants: An Overview

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  1. Middle Ear Implants: An Overview Jonathan H. Spindel, Ph.D. Sensory-Neural Engineering Research Laboratory College of Integrated Science and Technology James Madison University, Harrisonburg, Virginia http://sharepoint.cisat.jmu.edu/isat/spindejh/presentations e-mail: spindejh@jmu.edu

  2. Hearing Loss Worldwide • Estimated 250 million people have disabling hearing impairment, defined as hearing loss that measures in the moderate through profound ranges in the better ear… • This represents approximately 4.2 percent of the world’s population, a much higher prevalence than was previously thought… * Hearing Health, Volume 20:2, Summer 2004

  3. Rehabilitative Role of the Hearing Aid Hearing aids provide for partial rehabilitation by amplifying the vibrational energy delivered to the inner ear using acoustic energy applied to the TM.

  4. Some U.S. hearing aid market data... • 27.2 million impaired individuals • 5.6 million hearing aid users • 21.7 million hearing impaired non-users • 20.4% market penetration across all age groups • <55% of users reported being “satisfied” • <10% for 0-54 years of age Why don’t more people use hearing aids?

  5. Conventional Hearing Aids: Inherent Problems acoustic feedback (requirement for ear mold) • introduced distortion • long-wear comfort • external canal infections • difficult to fit problem anatomies effectiveness in background noise appearance and hearing aid stigmas

  6. Implantable Middle Ear Hearing Devices

  7. Transducer Placement

  8. What is an IMEHD? A hearing amplification device in which vibrational energy is delivered to the ear using implanted components. Different from a cochlear implant: • Residual cochlear function is utilized. • IHD sensation is “sound-like.” Different from bone vibrators (i.e. BAHA): • Better potential for high gain application. • Capable of providing wide-band amplification.

  9. Improvements on Acoustic Devices • direct vibrational drive (one less transduction step) • no distortion from small speaker element • generally eliminates need for ear mold (no feedback) • can fit problematic anatomies and conductive losses • increased long-term wear comfort • improvements in signal processing and noise management • alternative device for non-compliant patient population

  10. IHDs: Design Considerations • Addresses feedback, occlusion, distortion • Preserves residual hearing • Minimal risks (surgery, infection) • Cost-effective (over the life of the device) • Permits the full range of normal activities • Improves the user’s quality of life…

  11. Overall Goals Targeting moderate to severe hearing impairment or patients with significant inoperable conductive losses. Given a high level of patient dissatisfaction and non-use of conventional hearing devices, however, IHD technology may offer advances which attract many potential users that are not currently interested in pursuing amplification.

  12. For many patients implants may be the only remaining option! Tortuous and small ear canals Unmanageable feedback Chronic EAC issues Irritation, swelling & pain, infection, contact dermatitis Unacceptable fit Chronic cerumen production Environmental factors that prevent HA use Chronic unresolved middle ear issues

  13. Key Element: Implantable Transducer Transducer: A device which changes one form of energy into another.

  14. Transducers • Piezoelectric • (Fixed-End vs. Diaphragm) • Electromagnetic • (Intra-magnetic vs. Extra-magnetic)

  15. Piezoelectric Transducers Fixed End (Spring Board) Fixed Diaphragm (Piston)

  16. Electromagnetic Transducers Extra-Coil Magnetic Intra-Coil Magnetic

  17. Piezokinetic • reliable and controllable in design • disconnection, disarticulation or restriction of the ossicular chain Electrokinetic • non-fixed driver, unfocused power (design dependent) • potential for loading or movement-driven system damage • (current data indicates minimal loading and no evidence of ossicular risk)

  18. Implantable Hearing Devices… 1 part inspiration 4 parts perspiration 5 parts desperation! NOTE Innovation is…

  19. Investigation Teams: Ball et al. Dumon et al. Fredrickson et al. Goode et al. Hough et al. Kartush and Tos Maniglia et al. Snik et al. Spindel et al. Suzuki et al. Tjellstrom et al. Welling and Barnes Yanagihara et al. Industrial Ventures: Implex (Germany) Nobel Industries (Sweden) Otologics Resound Rian (Japan) Richards Smith and Nephew SoundTec St. Croix Medical Symphonix (Siemens) Xomed-Treace IHD R&D: Past and Present

  20. MEIHDs: An Overview

  21. Envoy Medical (formerly St. Croix Medical) “Esteem” - Totally Implantable Hearing System Images courtesy of Envoy Medical

  22. PiezoSensor

  23. Piezo Driver

  24. The Complete Esteem System Commander Programmer Piezo Driver Sound Processor Personal Programmer Piezo Sensor

  25. Esteem System Placement • Incus resection (2-3mm) • Sound processor • Sensor attached to incus • Driver attached to stapes Note: Company reports life expectancy of implant battery to be 3-4 years…

  26. Esteem Surgical Procedure • Single Step Procedure • Most common • All implantation and connection of all components occur in one procedure • Average surgical time – 4 hours • Two Step Procedure • Discretion of Surgeon • May be used with very small facial recess • All components implanted in first step • Sensor attached in first step • Driver attached in second step

  27. 18 years old Symmetrical Sensorineural Hearing Loss No fluctuation No sudden unknown cause of HL Normal middle ear Word Recognition of 60% or better Current HA user Patient Selection Criteria

  28. Esteem Surgical Procedure Step One: Perform mastoidectomy and create Sound Processor bed

  29. Esteem Surgical Procedure Step Two: Open the facial recess to allow placement of the transducers Step Three: The incus is resected (2-3mm)

  30. Esteem Surgical Procedure Step Four: Driver transducer: attached to Stapes Note: If doing a 2-step procedure, this is done as part of Second Step Step Five: Sensor transducer: attached to Incus Note: Glasscock stabilizer used for positioning transducers during the procedure – these are removed. Transducer are fixed in place with mimix in the mastoid cavity

  31. Esteem Surgical Procedure Step Six: Connect the Driver and Sensor leads into the header of the Sound Processor Step Seven: Secure the sound Processor in the bony bed created earlier

  32.  Status Check: Envoy • Feasibility implantation performed in Europe (6) and US (7) (First objective chronic human clinical data reported at AAO. Results similar between US and EU trials.) • US: 5 implants functioning (10-20 dB for 500-2K); low output (<5 dB) for frequencies above 2K (3 still functioning today, 3 explanted) • US: 2 non-functioning • EU: Results similar to US (3 re-implanted with new, 3 off/explanted) • US: Start in April/May to be implanted with new systems

  33.  Status Check: Envoy Medical • Feasibility trial complete • Proved concept • Improved design of components • Incased in titanium and gold, increased hermeticity • Increased robustness of system • Pivotal (PMA) trial currently underway (expect PMA in Fall 2006) • 7 US sites (5 current), 4 German Sites • 50 to 75 subjects to be implanted (45 (38 on), 30-35 pending surgery) • Of current subjects: 4 US / 1 EU ~27 dB (500, 1, 2 average) • Sound-field for 1 subject: • Unaided • Aided • Envoy

  34. Pivotal Trial: Air Conduction

  35. Pivotal Trial: Functional Gain(Warble Tones in Sound Field)

  36. Pivotal Trial: SRT

  37. Pivotal Trial: WRS at 50 dB HL

  38. MET™ Ossicular Stimulator (Semi-Implantable) External Audio Processor Internal Receiver & Transducer

  39. Thresholds and Functional Gain

  40.  Status Check: Otologics • Phase I completed 2001(n = 9), Planned Phase II (n = 104)

  41.  Status Check: Otologics • Phase I: n = 9 (completed 2001) • CE Mark obtained July 2001 Subjective report of superior, natural sound quality Objective clinical data was limited, proving feasibility • Initiated Phase II: n = 104 Scheduled for completion 4th quarter 2002 Planned PMA submission complete by 4th quarter 2002 • April 2003 Otologics voluntary suspended the US clinical trial and ceased sales in the EU

  42.  Status Check: Otologics • Problems centered around: • Fragility/Reliability of the transducer • Could be damaged during manufacturing, shipping, implanting • Coupling/Loading difficult for surgeons • Too little loading = poor patient benefit/limited gain • Too much loading = conductive loss and/or Transducer Damage • New surgical instrumentation introduced to address problems • EU Sales resumed September 2003 • Decision to re-enter the US market with a totally implantable version

  43. “Carina” MET Fully-Implantable System Remote Implant Charging System

  44. Implant Microphone Digital Signal Processor Battery IS-1 Connector Lead Receiver Coil Magnet Transducer

  45. Implant Charger • Recharges battery of implant • Daily recharge takes less than 1 hour • Patient can use implant during recharge Base Station • Charges implant charger • Battery life: > 12 years (5 year warrantee)• Battery recharge time: 60-90 minutes• Battery recharge frequency: daily• Frequency Range: < 200 to 6250 Hz• Processor Type: 12 Band, 2 Ch. DSP

  46. Volume On/Off Remote

  47. NOAHlink™ System Fitting System Diagnostic System Programming System

  48. Upgrade Surgical Procedure Semi-Implantable Fully-Implantable

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