BONEBRIDGE Bone Conduction Implant in Adults

  • STATUS
    Recruiting
  • End date
    Apr 19, 2022
  • participants needed
    30
  • sponsor
    Med-El Corporation
Updated on 19 August 2021
anesthesia
ct scan
general anesthesia
deafness
AIDS
mixed hearing loss

Summary

Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.

Details
Condition Mixed conductive and sensorineural hearing loss, Conductive hearing loss, mixed hearing loss
Treatment Bonebridge
Clinical Study IdentifierNCT03859648
SponsorMed-El Corporation
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults, 18 years of age or older at the time of implantation
Conductive or mixed hearing loss, defined as
Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz
Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz
Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz
Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better
Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears
Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
Able to complete testing materials in English
CT scan indicating the patient's anatomy is adequate to enable placement of the implant
Ability to undergo general anesthesia
Appropriate motivation and expectation levels
Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria

Evidence that hearing loss is retrocochlear in origin
Skin or scalp condition precluding use of external audio processor
Suspected cognitive impairment or organic brain dysfunction
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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