Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Advanced Bionics
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.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
You may not be if
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
Clareo Health | Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
