Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids

January 13, 2022 updated by: Starkey Laboratories, Inc

Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids

This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.

Study Type

Interventional

Enrollment (Actual)

34

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
    • Minnesota
      • Eden Prairie, Minnesota, United States, 55344
        • Starkey

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

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults, minimum age of 18
  • Native English speakers
  • Ability to complete questionnaires and laboratory assessments
  • Symmetric, mild to moderately-severe sensorineural hearing loss
  • Informed consent completed with signature

Exclusion Criteria:

  • Inability to visit the Starkey Headquarters building for testing
  • Central or middle ear hearing problems
  • Medical contraindications to wearing hearing aids
  • Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearing Aid 1
New Receiver-in-Canal device, successor of previous device generation
Device: Legacy Receiver-in-Canal Device
Receiver-in-canal device available on the market
Active Comparator: Hearing Aid 2
Legacy Receiver-in-Canal device that is currently available on the market
Device: New Receiver-in-Canal Device
Successor of previous device generation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
Time Frame: Four weeks
IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure.
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids
Time Frame: Four weeks
This data will be collected through lab testing following the first fit of the hearing aids. Participants will answer questionnaire items related to their impressions of sound quality. Results will be collected using a 7-point Likert scale, and ratings (1-7) will be analyzed using descriptive statistics. Statistical measures for repeated measurements will be used to understand any differences between hearing aid conditions.
Four weeks
Safety of the new, receiver-in-canal devices through tracking of adverse events
Time Frame: Four weeks
This data will be collected through the tracking of adverse events.
Four weeks

Collaborators and Investigators

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

Sponsor

Starkey Laboratories, Inc

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)

October 25, 2021

Primary Completion (Actual)

January 10, 2022

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR 21001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

No

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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