Baseline Performance and Fitting Parameters for Sonova Products

Advanced Bionics

Status

Invitation-only

Conditions

Hearing Disorders

Ear Diseases

Hearing Loss

Otolaryngological Disease

Treatments

Device: Pinna-located microphone

Device: Pinna-simulated microphone algorithm

Study type

Interventional

Funder types

Industry

Identifiers

NCT05859568

CPR2301

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.

Full description

This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.

Enrollment

20 estimated patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability to provide Informed Consent/Assent
Adults (age +18 years) and children (8-17 years) can be enrolled in this study
- If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities
Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
English language proficiency as determined by the investigator

Exclusion criteria

• Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints