Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Hearing Loss, Ear Diseases, Hearing Disorders
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility 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
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Other
Other
Electric Only
Aidable Residual Hearing