Phonak Behind-The-Ear Quality Evaluation

August 18, 2023 updated by: Sonova AG
Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

Study Type

Interventional

Enrollment (Actual)

7

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

Inclusion Criteria:

  • Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
  • 18+ years old
  • Good written and spoken English language skills
  • Able to fill in a questionnaire conscientiously
  • Experienced hearing aid user
  • Able to produce a reliable hearing test result
  • Able to describe listening impressions/experiences and the use of the hearing aids

Exclusion Criteria:

  • Not willing to test the hearing aids
  • Has auricle deformities that prevents secure placement of the hearing aids
  • Has limited mobility and is not able to attend the appointments
  • Not willing to wear the hearing aids for at least 8 hours per day
  • Known hypersensitivity or allergy with synthetic materials
  • Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
  • Hints of psychological problems
  • Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)

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: New BTE hearing aid first, then legacy BTE hearing aid
All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid.
Device: Phonak Naida BTE hearing aid
Newest generation of ultra-power Phonak BTE hearing aids
Device: Phonak Naida legacy BTE hearing aid
Previous model/generation of the Naida BTE hearing aid
Experimental: Legacy BTE hearing aid first, then new BTE hearing aid
All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid.
Device: Phonak Naida BTE hearing aid
Newest generation of ultra-power Phonak BTE hearing aids
Device: Phonak Naida legacy BTE hearing aid
Previous model/generation of the Naida BTE hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective measure of listening effort
Time Frame: Day 14 of the study
A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test.
Day 14 of the study
Speech in Noise Test
Time Frame: Day 14 of the study
Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance.
Day 14 of the study

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)

July 17, 2023

Primary Completion (Actual)

August 16, 2023

Study Completion (Actual)

August 16, 2023

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-12872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared outside of Sonova research departments.

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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