Baseline Performance and Fitting Parameters for Sonova Products
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pinna-located microphone, Pinna-simulated microphone algorithm.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
Detailed 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.
Interventions
- Device Pinna-located microphone
Sound processors using a pinna-located microphone - Device Pinna-simulated microphone algorithm
Sound processors using a pinna-simulated algorithm
Primary outcome measures
- Speech performance in noise [Time frame: 1 day]
Secondary outcome measures (2)
- Localization performance [Time frame: 1 day]
- Analysis of usability and preference questionnaire [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Advanced Bionics — Valencia
Identifiers
NCT: NCT05859568 · CPR2301