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Investigating Hearing Aid Frequency Response Curves

Primary Purpose

Hearing Loss, Sensorineural, Hearing Loss, Bilateral

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hearing Aid - Standard Curve
Hearing Aid - Variation #1
Hearing Aid - Variation #2
Hearing Aid - Variation #3
Hearing Aid - Variation #4
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Hearing Loss, Hearing Aids, Frequency Response Curves

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • N2 - N4 Hearing losses
  • Health Outer ear
  • no visible congenital or traumatic deformity of the outer ear
  • Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
  • Ability to answer questions and repeat sentences
  • No history of problematic tinnitus or pain/discomfort from loud sounds
  • No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature
  • Willingness to wear different styles of couplings
  • Willingness to wear binaural fitting
  • Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them)
  • Ability to travel throughout facility

Exclusion Criteria:

  • Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
  • Limited mobility/not able to come to the scheduled visit
  • Inability to produce reliable hearing test results
  • History of active drainage from the ear in the previous 90 days
  • Abnormal appearance of the eardrum and ear canal.

Sites / Locations

  • Sonova - Kitchener

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Hearing Loss

Arm Description

Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.

Outcomes

Primary Outcome Measures

Sound Quality Rating - Streamed
Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred.

Secondary Outcome Measures

Sound Quality Rating - Live
Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and determine which program they prefer to listen to. Participants will be asked to make ratings in the lab, outdoors, and the cafeteria. Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Highers scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.

Full Information

First Posted
August 26, 2022
Last Updated
January 23, 2023
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT05521308
Brief Title
Investigating Hearing Aid Frequency Response Curves
Official Title
Investigating Hearing Aid Frequency Response Curves
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
January 11, 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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.
Detailed Description
Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Keywords
Hearing Loss, Hearing Aids, Frequency Response Curves

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with Hearing Loss
Arm Type
Experimental
Arm Description
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Intervention Type
Device
Intervention Name(s)
Hearing Aid - Standard Curve
Intervention Description
Our current hearing aids which will be programmed to our standard frequency response curve.
Intervention Type
Device
Intervention Name(s)
Hearing Aid - Variation #1
Intervention Description
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Intervention Type
Device
Intervention Name(s)
Hearing Aid - Variation #2
Intervention Description
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Intervention Type
Device
Intervention Name(s)
Hearing Aid - Variation #3
Intervention Description
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Intervention Type
Device
Intervention Name(s)
Hearing Aid - Variation #4
Intervention Description
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Primary Outcome Measure Information:
Title
Sound Quality Rating - Streamed
Description
Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Sound Quality Rating - Live
Description
Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and determine which program they prefer to listen to. Participants will be asked to make ratings in the lab, outdoors, and the cafeteria. Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Highers scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: N2 - N4 Hearing losses Health Outer ear no visible congenital or traumatic deformity of the outer ear Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz. Ability to answer questions and repeat sentences No history of problematic tinnitus or pain/discomfort from loud sounds No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature Willingness to wear different styles of couplings Willingness to wear binaural fitting Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them) Ability to travel throughout facility Exclusion Criteria: Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products) Limited mobility/not able to come to the scheduled visit Inability to produce reliable hearing test results History of active drainage from the ear in the previous 90 days Abnormal appearance of the eardrum and ear canal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyu Qian, PhD
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova - Kitchener
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2E 1Y6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32976346
Citation
Vaisberg J, Folkeard P, Levy S, Dundas D, Agrawal S, Scollie S. Sound Quality Ratings of Amplified Speech and Music Using a Direct Drive Hearing Aid: Effects of Bandwidth. Otol Neurotol. 2021 Feb 1;42(2):227-234. doi: 10.1097/MAO.0000000000002915.
Results Reference
background
PubMed Identifier
30461418
Citation
Harianawala J, Galster J, Hornsby B. Psychometric Comparison of the Hearing in Noise Test and the American English Matrix Test. J Am Acad Audiol. 2019 Apr;30(4):315-326. doi: 10.3766/jaaa.17112. Epub 2018 Sep 25.
Results Reference
background
PubMed Identifier
29466265
Citation
Wu YH, Stangl E, Chipara O, Hasan SS, Welhaven A, Oleson J. Characteristics of Real-World Signal to Noise Ratios and Speech Listening Situations of Older Adults With Mild to Moderate Hearing Loss. Ear Hear. 2018 Mar/Apr;39(2):293-304. doi: 10.1097/AUD.0000000000000486.
Results Reference
background
PubMed Identifier
7963011
Citation
Neuman AC, Bakke MH, Hellman S, Levitt H. Effect of compression ratio in a slow-acting compression hearing aid: paired-comparison judgments of quality. J Acoust Soc Am. 1994 Sep;96(3):1471-8. doi: 10.1121/1.410289.
Results Reference
background

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Investigating Hearing Aid Frequency Response Curves

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