NCT05828017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

March 24, 2023

Results QC Date

December 5, 2023

Last Update Submit

March 10, 2025

Conditions

Hearing Loss, SensorineuralHearing Loss, Bilateral

Keywords

Hearing LossHearing AidsFrequency Response Curves

Outcome Measures

Primary Outcomes (12)

  • Sound Quality Ratings - Listening Comfort - Program 1

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Overall Preference - Program 1

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Speech Clarity - Program 1

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. 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). Higher 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.

    10 minutes

  • Sound Quality Ratings - Noise Intrusion - Program 1

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Listening Comfort - Program 2

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Overall Preference - Program 2

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Noise Intrusion - Program 2

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Listening Comfort - Program 3

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Overall Preference - Program 3

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Speech Clarity - Program 3

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. 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). Higher 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.

    10 minutes

  • Sound Quality Ratings - Noise Intrusion - Program 3

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. 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). Higher 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.

    10 Minutes

  • Sound Quality Ratings - Overall Preference - Program 4

    Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.

    10 Minutes

Secondary Outcomes (2)

  • US Matrix Test in Noise Results - dB SNR 50%

    30 Minutes

  • Sound Quality Ratings - Streaming

    1 hour

Study Arms (1)

Participants with Hearing Loss

EXPERIMENTAL

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.

Other: Hearing Aid - Standard Curve under Program 1Device: Hearing Aid - Variation #1 under Program 1Other: Hearing Aid - Variation #2 under Program 5 - Streaming OnlyOther: Hearing Aid - Variation #3 under Program 5 - Streaming OnlyOther: Hearing Aid - Variation #4under Program 5 - Streaming OnlyOther: Hearing Aid - Standard Curve under Program 2Other: Hearing Aid - Variation #1 under Program 2Other: Hearing Aid - Standard Curve under Program 3Other: Hearing Aid - Variation #1 under Program 3Other: Hearing Aid - Standard Curve under Program 4Other: Hearing Aid - Variation #1 under Program 4Other: Unaided

Interventions

Hearing Aid - Standard Curve under Program 1OTHER

Our current hearing aids which will be programmed to our standard frequency response curve.

Participants with Hearing Loss
Hearing Aid - Variation #1 under Program 1DEVICE

Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.

Participants with Hearing Loss
Hearing Aid - Variation #2 under Program 5 - Streaming OnlyOTHER

Our current hearing aids which will be programmed to our standard frequency response curve.

Participants with Hearing Loss
Hearing Aid - Variation #3 under Program 5 - Streaming OnlyOTHER

Hearing aids that will have the frequency response curve #3 adjusted and fit to the participant's hearing loss.

Participants with Hearing Loss
Hearing Aid - Variation #4under Program 5 - Streaming OnlyOTHER

Hearing aids that will have the frequency response curve #4 adjusted and fit to the participant's hearing loss.

Participants with Hearing Loss
Hearing Aid - Standard Curve under Program 2OTHER

Our current hearing aids which will be programmed to our standard frequency response curve.

Participants with Hearing Loss
Hearing Aid - Variation #1 under Program 2OTHER

Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.

Participants with Hearing Loss
Hearing Aid - Standard Curve under Program 3OTHER

Our current hearing aids which will be programmed to our standard frequency response curve.

Participants with Hearing Loss
Hearing Aid - Variation #1 under Program 3OTHER

Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.

Participants with Hearing Loss
Hearing Aid - Standard Curve under Program 4OTHER

Our current hearing aids which will be programmed to our standard frequency response curve.

Participants with Hearing Loss
Hearing Aid - Variation #1 under Program 4OTHER

Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.

Participants with Hearing Loss
UnaidedOTHER

No hearing aids worn at all and participants tested as is.

Participants with Hearing Loss

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonova - Kitchener

Kitchener, Ontario, N2E 1Y6, Canada

Location

Related Publications (7)

  • 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.

    PMID: 32976346BACKGROUND

  • 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.

    PMID: 30461418BACKGROUND

  • 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.

    PMID: 29466265BACKGROUND

  • 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.

    PMID: 7963011BACKGROUND

  • Caswell-Midwinter B, Whitmer WM. Discrimination of Gain Increments in Speech-Shaped Noises. Trends Hear. 2019 Jan-Dec;23:2331216518820220. doi: 10.1177/2331216518820220.

    PMID: 30803400BACKGROUND

  • 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.

    PMID: 25690777BACKGROUND

  • 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.

    PMID: 20724358BACKGROUND

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss, BilateralHearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Bilal Sheikh - Research Audiologist
Organization
Sonova
bilal.sheikh@sonova.com
2268083260

Study Officials

  • Jinyu Qian, PhD

    Sonova AG

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participant were blinded to the type of intervention (i.e., hearing aid curve) or program they were comparing or rating. They were simply asked to specify which intervention they had a preference for.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study is not a crossover study in it's true sense as there is only one arm. All participants will undergo all testing and will test each hearing aid variation. It should be noted that testing a different hearing aid variation (i.e., intervention) is done by simply clicking a button and having the hearing aid switch into a different variation. In this study, participants will go back and forth between different variations in order to make preference selections (Live Sound Quality or US Matrix Test task). Additionally, in other outcome measures, participants will listen to pre-recorded stimuli that have the various frequency response curves applied. In this case, participants once again will be exposed to different hearing aid curves while simply listening via headphones and making preference selections. In the end, participants can be exposed to different hearing aid variations (i.e., interventions) simultaneously and have the ability to go back and forth between interventions.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 25, 2023

Study Start

May 1, 2023

Primary Completion

October 11, 2023

Study Completion

October 11, 2023

Last Updated

March 18, 2025

Results First Posted

March 18, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)