Back to resultsPhonak Behind-The-Ear Quality Evaluation
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonak Naida BTE hearing aid
Phonak Naida legacy BTE hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
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)
Sites / Locations
- Phonak Audiology Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
New BTE hearing aid first, then legacy BTE hearing aid
Legacy BTE hearing aid first, then new BTE hearing aid
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Speech in Noise Test
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.
Subjective measure of listening effort
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05956808
Brief Title
Phonak Behind-The-Ear Quality Evaluation
Official Title
Phonak Behind-The-Ear Quality Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This investigation model is a cross-over design, randomized, and is single-blinded.
Masking
Participant
Masking Description
Participants will be blinded as to which hearing device they are wearing during lab testing.
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New BTE hearing aid first, then legacy BTE hearing aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Legacy BTE hearing aid first, then new BTE hearing aid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Phonak Naida BTE hearing aid
Intervention Description
Newest generation of ultra-power Phonak BTE hearing aids
Intervention Type
Device
Intervention Name(s)
Phonak Naida legacy BTE hearing aid
Intervention Description
Previous model/generation of the Naida BTE hearing aid
Primary Outcome Measure Information:
Title
Speech in Noise Test
Description
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.
Time Frame
Day 14 of the study
Title
Subjective measure of listening effort
Description
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.
Time Frame
Day 14 of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Phonak Audiology Research Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared outside of Sonova research departments.
Learn more about this trial
Phonak Behind-The-Ear Quality Evaluation
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