Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE

Med-El Corporation3 sites in 2 countries9 target enrollmentAugust 26, 2019

ConditionsHearing Loss, Conductive Hearing Loss, Mixed

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hearing Loss, Conductive
Sponsor: Med-El Corporation
Enrollment: 9
Locations: 3
Primary Endpoint: Number and Proportion of Subjects Experiencing Device Related Adverse Events
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 26, 2019

End Date

November 4, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Med-El Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Number and Proportion of Subjects Experiencing Device Related Adverse Events

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

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

Percentage Change in AZ Bio Sentence Score in Noise

Time Frame: Baseline and 3 months post activation

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

Secondary Outcomes

Number of Subjects With Stable or Better Soundfield Thresholds(Baseline and 3 months post activation)
Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance(Baseline and 3 months post activation)
Percentage Change in CNC Word Score(Baseline and 3 months post activation)
Number of Subjects With Stable Unaided Bone Conduction Thresholds(Baseline and 2 weeks post surgery)