BONEBRIDGE Bone Conduction Implant in Adults

Launched by MED-EL CORPORATION · Feb 28, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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