BONEBRIDGE Bone Conduction Implant in Adults (NCT03859648) | Clinical Trial Compass
TerminatedNot Applicable
BONEBRIDGE Bone Conduction Implant in Adults
Stopped: Slow enrollment due to COVID-19
United States, Canada9 participantsStarted 2019-08-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number and Proportion of Subjects Experiencing Device Related Adverse Events
Timeframe: Up to three (3 months) post activation
2
Percentage Change in AZ Bio Sentence Score in Noise