Speech Locator In-car Performance Evaluation

NCT ID: NCT05054816

Last Updated: 2025-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2022-03-11

Brief Summary

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Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single cohort of participants will receive and be assessed in all treatment/intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Hearing aid processing settings are randomized and double blinded.

Study Groups

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Participants with hearing loss.

Participants with hearing loss.

Group Type EXPERIMENTAL

Investigational adaptive directional microphone strategy

Intervention Type DEVICE

A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.

Comparator omnidirectional microphone strategy

Intervention Type DEVICE

A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.

Comparator fixed directional microphone strategy

Intervention Type DEVICE

A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.

Interventions

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Investigational adaptive directional microphone strategy

A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.

Intervention Type DEVICE

Comparator omnidirectional microphone strategy

A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.

Intervention Type DEVICE

Comparator fixed directional microphone strategy

A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults (18-99 years) with ≥3 months hearing aid experience
* binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss
* fluent in English

Exclusion Criteria

* children/teenagers
* normal hearing or hearing loss exceeding N5 (severe) by 10 dB
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova Canada Inc.

INDUSTRY

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sonova Innovation Centre Toronto

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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SRF-459

Identifier Type: -

Identifier Source: org_study_id

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