Expanded Indications in the Pediatric BONEBRIDGE Population (NCT05615649) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Expanded Indications in the Pediatric BONEBRIDGE Population
United States36 participantsStarted 2023-10-03
Plain-language summary
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
Who can participate
Age range3 Years – 12 Years
SexALL
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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