NCT05521308

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

August 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 24, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 24, 2025

Completed
Last Updated

March 24, 2025

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

August 26, 2022

Results QC Date

November 21, 2023

Last Update Submit

March 10, 2025

Conditions

Hearing Loss, SensorineuralHearing Loss, Bilateral

Keywords

Hearing LossHearing AidsFrequency Response Curves

Outcome Measures

Primary Outcomes (1)

  • Streaming Sound Quality Ratings

    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.

    60 minutes

Secondary Outcomes (3)

  • Sound Quality Rating - Live - Counts

    60 minutes

  • Sound Quality Rating - Live - Preferences

    60 minutes

  • US Matrix Test in Quiet - SRT

    30 Minutes

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.

Device: Hearing Aid - Standard CurveDevice: Hearing Aid - Variation #1Device: Hearing Aid - Variation #2Device: Hearing Aid - Variation #3Device: Hearing Aid - Variation #4

Interventions

Hearing Aid - Standard CurveDEVICE

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

Participants with Hearing Loss
Hearing Aid - Variation #1DEVICE

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

Participants with Hearing Loss
Hearing Aid - Variation #2DEVICE

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

Participants with Hearing Loss
Hearing Aid - Variation #3DEVICE

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

Participants with Hearing Loss
Hearing Aid - Variation #4DEVICE

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

Participants with Hearing Loss

Eligibility Criteria

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

You may qualify if:

  • 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

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 (4)

  • 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

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
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 task 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 hearing aids and making preference selections. In the end, participants can be exposed to different hearing aid variations (i.e., interventions) simultaneously and also have the ability to go back and forth.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 30, 2022

Study Start

October 24, 2022

Primary Completion

January 11, 2023

Study Completion

January 11, 2023

Last Updated

March 24, 2025

Results First Posted

March 24, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)