BONEBRIDGE Bone Conduction Implant in Adults

Med-El Corporation9 enrolled

Overview

Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss, Conductive Hearing Loss, Mixed

Interventions

BONEBRIDGEDEVICE

Bone Conduction Implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults, 18 years of age or older at the time of implantation * Conductive or mixed hearing loss, defined as: * Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz * Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz * Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz * Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better * Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears * Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons * Able to complete testing materials in English * CT scan indicating the patient's anatomy is adequate to enable placement of the implant * Ability to undergo general anesthesia * Appropriate motivation and expectation levels * Stated willingness to comply with all study procedures for the duration of the study Exclusion Criteria: * Evidence that hearing loss is retrocochlear in origin * Skin or scalp condition precluding use of external audio processor * Suspected cognitive impairment or organic brain dysfunction

Locations (3)

The Ohio State Wexner Medical Center University

Columbus, Ohio, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

Number and Proportion of Subjects Experiencing Device Related Adverse Events

Adverse events will be collected and reported throughout the duration of the study.

Time frame: Up to three (3 months) post activation

Percentage Change in AZ Bio Sentence Score in Noise

Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation.

Time frame: Baseline and 3 months post activation

Secondary Outcomes

Percentage Change in CNC Word Score

Percent improvement in CNC word scores will be compared from baseline to 3 months post activation.

Time frame: Baseline and 3 months post activation

Number of Subjects With Stable or Better Soundfield Thresholds

The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds

Time frame: Baseline and 3 months post activation

Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance

The number of subjects with similar or better performance on the QuickSIN (Speech In Noise) task in the implanted ear compared to baseline performance

Time frame: Baseline and 3 months post activation

Number of Subjects With Stable Unaided Bone Conduction Thresholds

The number of subjects with stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.

Time frame: Baseline and 2 weeks post surgery

Data from ClinicalTrials.gov

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