BONEBRIDGE Bone Conduction Implant in Adults
- Conditions
- Hearing Loss, ConductiveHearing Loss, Mixed
- Interventions
- Device: BONEBRIDGE
- Registration Number
- NCT03859648
- Lead Sponsor
- Med-El Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bone Conduction Implant BONEBRIDGE All subjects will be implanted with the bone conduction implant.
- Primary Outcome Measures
Name Time Method Number and Proportion of Subjects Experiencing Device Related Adverse Events Up to three (3 months) post activation Adverse events will be collected and reported throughout the duration of the study.
Percentage Change in AZ Bio Sentence Score in Noise Baseline and 3 months post activation Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Stable or Better Soundfield Thresholds Baseline and 3 months post activation The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds
Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance Baseline and 3 months post activation The number of subjects with similar or better performance on the QuickSIN (Speech In Noise) task in the implanted ear compared to baseline performance
Percentage Change in CNC Word Score Baseline and 3 months post activation Percent improvement in CNC word scores will be compared from baseline to 3 months post activation.
Number of Subjects With Stable Unaided Bone Conduction Thresholds Baseline and 2 weeks post surgery The number of subjects with stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.
Trial Locations
- Locations (3)
The Ohio State Wexner Medical Center University
🇺🇸Columbus, Ohio, United States
The Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada