Clinical trial NCT05615649: Expanded Indications in the Pediatric BONEBRIDGE Population
Official title: Expanded Indications in the Pediatric BONEBRIDGE Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Conductive
Hearing Loss, Mixed
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.

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

Primary outcomes:
measure: Functional gain
timeFrame: Up to six (6) months post-activation
measure: Adverse events
timeFrame: Up to six (6) months post-activation
Secondary outcomes:
measure: Word recognition score
timeFrame: Up to six (6) months post-activation
measure: Unaided bone-conduction pure-tone average (BC-PTA)
timeFrame: Up to three (3) months post-activation
measure: Post-intervention quality-of-life questionnaire
timeFrame: Up to six (6) months post-activation
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health/Children's Hospital of Colorado
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Newark
country: United States
facility: University Hospital Newark/Rutgers New Jersey Medical School
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University/Nationwide Children's Hospital
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah Health/Primary Children's Hospital
state: Utah
Study officials:
References: