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Phonak Behind-The-Ear Quality Evaluation

Sponsor
Sonova AG (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05956808
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
28
Anticipated Duration (Days)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

Condition or Disease Intervention/Treatment Phase
  • Device: Phonak Naida BTE hearing aid
  • Device: Phonak Naida legacy BTE hearing aid
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This investigation model is a cross-over design, randomized, and is single-blinded.This investigation model is a cross-over design, randomized, and is single-blinded.
Masking:
Single (Participant)
Masking Description:
Participants will be blinded as to which hearing device they are wearing during lab testing.
Primary Purpose:
Treatment
Official Title:
Phonak Behind-The-Ear Quality Evaluation
Anticipated Study Start Date :
Jul 17, 2023
Anticipated Primary Completion Date :
Aug 14, 2023
Anticipated Study Completion Date :
Aug 14, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Speech in Noise Test [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.

  2. Subjective measure of listening effort [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Phonak Audiology Research Center Aurora Illinois United States 60504

Sponsors and Collaborators

  • Sonova AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sonova AG
ClinicalTrials.gov Identifier:
NCT05956808
Other Study ID Numbers:
  • SRF-12872
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 24, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural

Study Results

No Results Posted as of Jul 24, 2023