Expanded Indications in the Pediatric BONEBRIDGE Population

MED-EL

Status: Active, not recruiting

Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed

Treatments: Device: MED-EL BONEBRIDGE Bone Conduction Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05615649

G220197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Study procedure

Experimental group

Description:

This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.

Treatment:

Device: MED-EL BONEBRIDGE Bone Conduction Implant