Baseline Performance and Fitting Parameters for Sonova Products

NCT ID: NCT05859568

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2028-04-17

Brief Summary

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

Detailed Description

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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.

Conditions

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Hearing Loss Ear Diseases Hearing Disorders Otolaryngological Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microphone Location versus Microphone Algorithm Comparison

Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.

Group Type EXPERIMENTAL

Pinna-located microphone

Intervention Type DEVICE

Sound processors using a pinna-located microphone

Pinna-simulated microphone algorithm

Intervention Type DEVICE

Sound processors using a pinna-simulated algorithm

Interventions

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Pinna-located microphone

Sound processors using a pinna-located microphone

Intervention Type DEVICE

Pinna-simulated microphone algorithm

Sound processors using a pinna-simulated algorithm

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Bionics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Advanced Bionics

Valencia, California, United States

Site Status

Countries

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United States

Other Identifiers

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CPR2301

Identifier Type: -

Identifier Source: org_study_id

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