Preference Comparisons for Algorithms to Hear Speech

NCT ID: NCT05561335

Last Updated: 2023-09-07

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2023-10-31

Brief Summary

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Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.

Detailed Description

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People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.

This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.

Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.

Conditions

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Hearing Loss

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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Hearing Aid use for listening to speech in a common difficult situation

The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.

Group Type EXPERIMENTAL

hearing aid -novel program

Intervention Type DEVICE

novel microphone configuration

hearing aid - standard program

Intervention Type DEVICE

standard microphone configuration

Interventions

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hearing aid -novel program

novel microphone configuration

Intervention Type DEVICE

hearing aid - standard program

standard microphone configuration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Including adults with sensorineural mild to moderate-severe hearing loss
* hearing aid experience (greater than 6 months)
* who are able to complete the task in English.
* Language: Can speak and understand English Fluently

Hearing loss within the fitting ranges of the investigational products.

* Healthy outer ear.
* Ability to understand instructions.
* Ability to describe listening experiences.
* Ability to fill out questionnaires.
* Informed consent as documented by signature.

Exclusion Criteria

* Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product).
* Limited mobility and not able to attend to appointments or not able to go in a car.
* Reported symptoms of vertigo and dizziness by subject.
* Severe Tinnitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western University

OTHER

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Scollie, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University (aka The University of Western Ontario)

Locations

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Western University

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Don Hayes, PhD

Role: CONTACT

519 500 3618

Facility Contacts

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Paula Folkeard, AuD

Role: primary

519-661-2111 ext. 88936

Other Identifiers

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5251

Identifier Type: -

Identifier Source: org_study_id

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