Back to resultsInvestigating Hearing Aid Frequency Response Curves 2
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
Sponsored by
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
Inclusion Criteria: N3 - N5 Hearing losses Healthy 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 days Willingness to wear different styles of couplings Willingness to wear binaural fitting Experienced Users = more than 3 months of hearing aid experience Ability to travel to Sonova facilities 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 Ratings - Listening Comfort
Participants will be asked to wear hearing aids and as they are exposed to various listening environments. They will be asked to toggle between the two hearing aid programs and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth.
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 ran 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.
Reasonings for why ratings were made will also be noted.
Sound Quality Ratings - Overall Preference
Participants will be asked to wear hearing aids and as they are exposed to various listening environments. They will be asked to toggle between the two hearing aid programs and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth.
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.
Reasonings for why ratings were made will also be noted.
Secondary Outcome Measures
Speech Reception Threshold (SRT) Scores
Participant's SRT scores will be measured under the current freqency response curve and the proposed frequency response curve. They will also be tested without any hearing aids on.
Scores will differ based on each participant's hearing loss. Higher scores indicate poorer performance whereas lower scores indicate better performance in noisy situations. The test will be admistered to ensure that participants are able to achieve the same or better SRT scores with the proposed frequency response curve when compared to our current frequency response curve.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05828017
Brief Title
Investigating Hearing Aid Frequency Response Curves 2
Official Title
Investigating Hearing Aid Frequency Response Curves 2
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 11, 2023 (Actual)
Study Completion Date
October 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
Product Manufactured in and Exported from the U.S.
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. Based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. 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 and listener comfort. 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 and while in different listening enviroments.
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
20 (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.
Primary Outcome Measure Information:
Title
Sound Quality Ratings - Listening Comfort
Description
Participants will be asked to wear hearing aids and as they are exposed to various listening environments. They will be asked to toggle between the two hearing aid programs and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth.
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 ran 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.
Reasonings for why ratings were made will also be noted.
Time Frame
30 Minutes
Title
Sound Quality Ratings - Overall Preference
Description
Participants will be asked to wear hearing aids and as they are exposed to various listening environments. They will be asked to toggle between the two hearing aid programs and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth.
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.
Reasonings for why ratings were made will also be noted.
Time Frame
30 Minutes
Secondary Outcome Measure Information:
Title
Speech Reception Threshold (SRT) Scores
Description
Participant's SRT scores will be measured under the current freqency response curve and the proposed frequency response curve. They will also be tested without any hearing aids on.
Scores will differ based on each participant's hearing loss. Higher scores indicate poorer performance whereas lower scores indicate better performance in noisy situations. The test will be admistered to ensure that participants are able to achieve the same or better SRT scores with the proposed frequency response curve when compared to our current frequency response curve.
Time Frame
30 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:
N3 - N5 Hearing losses
Healthy 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 days
Willingness to wear different styles of couplings
Willingness to wear binaural fitting
Experienced Users = more than 3 months of hearing aid experience
Ability to travel to Sonova facilities
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
PubMed Identifier
30803400
Citation
Caswell-Midwinter B, Whitmer WM. Discrimination of Gain Increments in Speech-Shaped Noises. Trends Hear. 2019 Jan-Dec;23:2331216518820220. doi: 10.1177/2331216518820220.
Results Reference
background
PubMed Identifier
25690777
Citation
Smeds K, Wolters F, Rung M. Estimation of Signal-to-Noise Ratios in Realistic Sound Scenarios. J Am Acad Audiol. 2015 Feb;26(2):183-96. doi: 10.3766/jaaa.26.2.7.
Results Reference
background
PubMed Identifier
20724358
Citation
Bisgaard N, Vlaming MS, Dahlquist M. Standard audiograms for the IEC 60118-15 measurement procedure. Trends Amplif. 2010 Jun;14(2):113-20. doi: 10.1177/1084713810379609.
Results Reference
background
Learn more about this trial
Investigating Hearing Aid Frequency Response Curves 2
We'll reach out to this number within 24 hrs