Venting Effects on Speech Performance

May 1, 2025 updated by: Sonova AG
This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Phonak Audiology Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

  • 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

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
All participants will be tested using all three types of domes: Power, Vented, Open.
Device: Phonak Audeo Infinio Hearing Aid
Receiver-In-Canal hearing aid type that is coupled with either a custom earmold or a dome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AZ Bio Sentences
Time Frame: 1 day
Sentences will be presented at a pre-determined Signal-to-Noise Ratio (SNR). The SNR will be the same for all three conditions (Power dome, Vented dome, Open dome). Percent correct will be calculated for all conditions. A higher percentage indicates better performance.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Actual)

January 23, 2025

Study Completion (Actual)

January 23, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-26765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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