Expanded Indications in the Pediatric BONEBRIDGE Population

Launched by MED-EL CORPORATION · Nov 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of the MED-EL BONEBRIDGE Bone Conduction Implant for children under 12 years old who have conductive or mixed hearing loss. Conductive hearing loss happens when sound cannot properly travel through the outer or middle ear, while mixed hearing loss involves both conductive and sensorineural (inner ear) issues. The study aims to find out if this implant can help improve hearing in these children.

To participate, children need to be under 12 years old and have specific hearing test results that show they could benefit from the implant. They should also have enough bone structure in the ear for the surgery and have some experience with hearing aids. However, children under 3 years old, those with certain medical conditions, or those who have had previous hearing implants in the same ear cannot join. If eligible, participants can expect to undergo an evaluation, receive the implant if they qualify, and be monitored for their progress throughout the study. It's important for parents to commit to following all study procedures to help ensure accurate results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Under 12 years of age
• • Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted
• • Sufficient air-bone gap (ABG) at in the ear to be implanted
• • HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted
• • Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees
• • Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
• • Parental commitment to comply with all study procedures
• Exclusion Criteria:
• • Children under 3 years (36 months) of age
• • Chronic or non-revisable vestibular or balance disorders
• • Abnormally progressive hearing loss
• • Prior use of a hearing implant in the ear to be implanted
• • Current/ongoing use of a hearing implant in the contralateral/non-implant ear
• • Evidence that hearing loss is retrocochlear in origin
• • Medical condition that contraindicates implant surgery or anesthesia
• • Skin or scalp condition precluding use of external audio processor