Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Med-El Corporation
This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.
Age
3–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Expanded Indications in the Pediatric BONEBRIDGE Population
