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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease

Intervention / Treatment
-----------------
* Device: Remote Fitting
* Device: In-Office Fitting


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Electric Only<br> | Device: Remote Fitting<br>* Processors will be programmed using remote fitting application.<br>Device: In-Office Fitting<br>* Processors will be programmed using standard Target CI application.<br>|
| Other: Aidable Residual Hearing<br> | Device: Remote Fitting<br>* Processors will be programmed using remote fitting application.<br>Device: In-Office Fitting<br>* Processors will be programmed using standard Target CI application.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Performance in Quiet After Chronic Use (EO Only) | The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 2-3 weeks after fitting | 
| Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | Test performed 2-3 weeks after fitting |