Clinical trial NCT05034731: Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Official title: Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Ear Diseases
Hearing Disorders
Otolaryngological Disease
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Speech Performance in Quiet After Chronic Use (EO Only)
timeFrame: 2-3 weeks after fitting
measure: Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)
timeFrame: Test performed 2-3 weeks after fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References: