Expanded Indications in the Pediatric BONEBRIDGE Population

Hearing Loss, Conductive Clinical Trial

Official title:

Expanded Indications in the Pediatric BONEBRIDGE Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615649
• Other study ID #: G220197
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Med-El Corporation
• Contact: MED-EL Corporation
• Phone: 1-888-633-3524
• Email: research.us[@]medel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed
• Hearing Loss, Mixed Conductive-Sensorineural

Intervention

Device:
• MED-EL BONEBRIDGE Bone Conduction Implant
Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.

Locations

Country	Name	City	State
United States	University of Colorado Health/Children's Hospital of Colorado	Aurora	Colorado
United States	University of North Carolina	Chapel Hill	North Carolina
United States	The Ohio State University/Nationwide Children's Hospital	Columbus	Ohio
United States	University of Miami	Miami	Florida
United States	University Hospital Newark/Rutgers New Jersey Medical School	Newark	New Jersey
United States	University of Utah Health/Primary Children's Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional gain	Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds	Up to six (6) months post-activation
Primary	Adverse events	Number and proportion of subjects experiencing serious device- and surgery-related adverse events	Up to six (6) months post-activation
Secondary	Word recognition score	Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score	Up to six (6) months post-activation
Secondary	Unaided bone-conduction pure-tone average (BC-PTA)	Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA	Up to three (3) months post-activation
Secondary	Post-intervention quality-of-life questionnaire	Total and subscale scores on Glasgow Children's Benefit Inventory	Up to six (6) months post-activation