Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System

Advanced Bionics

Status

Completed

Conditions

Hearing Disorders

Ear Diseases

Hearing Loss

Otolaryngological Disease

Treatments

Device: Remote Fitting

Device: In-Office Fitting

Study type

Interventional

Funder types

Industry

Identifiers

NCT05034731

CR0121

Details and patient eligibility

About

This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.

Full description

The overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting.

Enrollment

19 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria All Subjects

Ability to provide Informed Consent/Assent
13 years of age or older
Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D)
Minimum of 6 months of CI experience with a minimum of 1 month experience with a Naída CI or Sky CI sound processor
At least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at Visit 1)
Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire (MDPQ-16)
English language proficiency as determined by the Investigator
Willingness to use a BTE sound processor for the duration of the study

Inclusion Criteria Specific to Aidable Residual Hearing Group

Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear for unilaterally implanted subjects and in both ears for bilaterally implanted subjects
Willingness to use an in-canal acoustic earhook for the duration of the study

Exclusion Criteria:

Clinical presentation indicative of potential implanted device malfunction
Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator