slide1 n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Middle Ear Implants: Concepts and Implementations PowerPoint Presentation
Download Presentation
Middle Ear Implants: Concepts and Implementations

Loading in 2 Seconds...

play fullscreen
1 / 42

Middle Ear Implants: Concepts and Implementations - PowerPoint PPT Presentation


  • 120 Views
  • Uploaded on

Middle Ear Implants: Concepts and Implementations. Jonathan H. Spindel, Ph.D. College of Integrated Science and Technology James Madison University, Harrisonburg, Virginia http://sharepoint.cisat.jmu.edu/isat/spindejh/presentations e-mail: spindel@cisat.jmu.edu. What is an MEIHD?.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Middle Ear Implants: Concepts and Implementations' - cyndi


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

Middle Ear Implants: Concepts and Implementations

Jonathan H. Spindel, Ph.D.

College of Integrated Science and Technology

James Madison University, Harrisonburg, Virginia

http://sharepoint.cisat.jmu.edu/isat/spindejh/presentations

e-mail: spindel@cisat.jmu.edu

what is an meihd
What is an MEIHD?

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
ihds design considerations
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…
note conventional hearing amplification is not viable for many patients due to
NOTE: Conventional hearing amplification is not viable for many patients due to…

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

Unresolved issues in conductive hearing loss

ihd r d past and present
Investigation Teams:

Ball et al.

Dumon et al.

Fredrickson et al.

Goode et al.

Hough et al.

Hüttenbrink 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

Nobel Industries

Otologics

Resound

Rian

Richards

Smith and Nephew

SoundTec

St. Croix Medical

Med El (Symphonix)

Xomed-Treace

IHD R&D: Past and Present
slide7

Envoy Medical (“Esteem” – TIMEIHD)

Images courtesy of

Envoy Medical

status check envoy medical
 Status Check: Envoy Medical
  • Feasibility trial complete
    • Proved concept
    • Improved design of components (titanium and gold,  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 average at 500, 1k, 2k
    • Minimal data reported to date
implant
Implant

Microphone

Digital Signal Processor

Battery

IS-1 Connector

Lead

Receiver Coil

Magnet

Transducer

slide11
Implant Charger
  • Recharges battery of implant
  • Daily recharge takes of approximately 1 hour
  • Patient can use implant during recharge

Base Station

  • Charges implant charger

Remote

Nominal Operating Parameters

• Battery life: > 12 years• Battery recharge time: 60 minutes (typical)• Battery recharge frequency: daily• Peak Output: 121 dB MET• Frequency Range: < 200 to 6250 Hz• Processor Type: 12 Band, 2 Ch. DSP

slide12

 Status Check: Otologics

  • Phase I clinical trial in US (9 subjects completed 2001)
  • CE Mark obtained July 2001
  • Initiated Phase II trial in US (n = 104)
  • April 2003 voluntary suspended US clinical trial and ceased sales in the EU
  • Problems were identified 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 world market with a totally implantable version
  • Currently 61 TI devices have been implanted (20 US, 41 EU/Asia)
vibrant soundbridge
Vibrant Soundbridge

Audio

Processor

VORP

Floating Mass

Transducer

Images courtesy of

Vibrant Med-El

status check vibrant med el
 Status Check: Vibrant Med-El
  • First patient implanted in EU in Sept. 1996
  • First patient implanted in US in October 1996
  • US clinical trial (100 patients) completed Summer 2000
  • FDA approval Summer 2000
  • Patients world-wide (>2000)
  • Multi-center clinical data presented in O-H&NS (Feb 2002)
  • >100 bilateral Vibrant patients (WW)
  • “Vibroplasty” study initiated this year to explore use in conductive loss
slide16

Reported patient selection criteria for Esteem, MET and Vibrant products(Note: Vibrant data includes proposed expansion pending FDA approval)

slide18

Development of a round window implantable hearing deviceJonathan H. Spindel, Paul R. Lambert, Roger A. Ruth(contributions by Michael A. Fuller)Department of Otolaryngology-HNS, University of Virginia, Charlottesville, Virginia, USADepartment of Integrated Science and Technology and Department of Communication Sciences and Disorders, James Madison University, Harrisonburg, Virginia, USA

slide19

RWEM

An electromagnetic approach using a magnet applied to the round window membrane.

the rwem concept
The RWEM concept...

direct vibrational input to the cochlea

no disarticulation or potential ossicular erosion

slide22

ACOUSTIC

RWEM

RWEM

ACOUSTIC

Frequency-Specific ABR (Threshold Measures)

slide24

Energy transfer to the cochlea using a round window implantable hearing device(a temporal bone study)Jonathan H. Spindel1 and Geoffrey Ball2Department of Integrated Science and Technology and Department of Communication Sciences and Disorders, James Madison University, Harrisonburg, Virginia, USA 1Institute for Applied Physics, University of Innsbruck, Innsbruck, Austria 2

slide25

A FMT on the round window can be used to develop higher gain device along with providing for alternative therapy options for problematic middle ear anatomies and inoperable conductive hearing loss

hypothesis
Hypothesis

Placement of a transducer closer to the cochlea will maximize energy transmission to the cochlea.

slide27

TB

ER-2

LDV

ER-7C

eac acoustic stimulus
EAC Acoustic Stimulus

ER-7C

LDV

ER-2

EAC

Middle Ear

OW

RW

LDV

i fmt stimulus
I-FMT Stimulus

ER-7C

LDV

EAC

Middle Ear

OW

I-FMT

RW

LDV

rw fmt stimulus
RW-FMT Stimulus

ER-7C

LDV

EAC

Middle Ear

OW

RW-FMT

RW

LDV

results summary rw fmt
Results Summary: RW-FMT
  • The RW-FMT is a viable implant approach
  • The FMT on the round window creates greater displacement of the cochlear fluid than the incus-mounted FMT
next steps
Next steps…
  • Investigate the RW-FMT clinically in a selected subject pool to ensure a standardized data set for evaluation (Med El vibroplasty study)
  • Provide regular and long-term measures to prove efficacy over time (Med El vibroplasty study)
  • Develop comparative result measures to support the utility of this approach compared to standard reconstructive procedures and BAHA
  • Use data to develop recommended surgical procedures that maximize device stability and performance for wider surgical use
slide41

Thanks!

http:\\sharepoint.cisat.jmu.edu\isat\spindejh\presentations