Venting Effects on Speech Performance

NCT ID: NCT06712693

Last Updated: 2025-05-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2025-01-23

Brief Summary

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This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.

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

Each participant will be fit with the investigational devices under three conditions: Power dome, Vented dome, and Open dome. Participant will complete the same tests under each condition. All participants will complete the same conditions.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants will know they are being fit with hearing aid, but will not be told which vent size or dome they are being fit with for any of the tests. The investigator scoring the speech test will not know which vent size/dome participant is wearing.

Study Groups

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Experimental

All participants will be tested using all three types of domes: Power, Vented, Open.

Group Type EXPERIMENTAL

Phonak Audeo Infinio Hearing Aid

Intervention Type DEVICE

Receiver-In-Canal hearing aid type that is coupled with either a custom earmold or a dome.

Interventions

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Phonak Audeo Infinio Hearing Aid

Receiver-In-Canal hearing aid type that is coupled with either a custom earmold or a dome.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-85 years of age
* Experienced hearing aid users
* N3-N4 hearing loss
* Fluent in English; ability to read and write in English
* Able to complete complex tasks
* Willing and able to provide informed consent
* Available for the data collection period

Exclusion Criteria

* Self-reported active ear-related pathology (otorrhea, dizziness, sudden hearing loss or worsening of hearing, otalgia)
* Visible deformity of the ear
* Chronic, severe tinnitus
* Unilateral hearing loss
* Cognitive impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phonak Audiology Research Center

Aurora, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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SRF-26765

Identifier Type: -

Identifier Source: org_study_id

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