Investigating Hearing Aid Frequency Response Curves 2

NCT ID: NCT05828017

Last Updated: 2025-03-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-10-11

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Sensorineural Hearing Loss, Bilateral

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Participants with Hearing Loss

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.

Group Type EXPERIMENTAL

Hearing Aid - Standard Curve under Program 1

Intervention Type OTHER

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

Hearing Aid - Variation #1 under Program 1

Intervention Type DEVICE

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

Hearing Aid - Variation #2 under Program 5 - Streaming Only

Intervention Type OTHER

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

Hearing Aid - Variation #3 under Program 5 - Streaming Only

Intervention Type OTHER

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

Hearing Aid - Variation #4under Program 5 - Streaming Only

Intervention Type OTHER

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

Hearing Aid - Standard Curve under Program 2

Intervention Type OTHER

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

Hearing Aid - Variation #1 under Program 2

Intervention Type OTHER

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

Hearing Aid - Standard Curve under Program 3

Intervention Type OTHER

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

Hearing Aid - Variation #1 under Program 3

Intervention Type OTHER

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

Hearing Aid - Standard Curve under Program 4

Intervention Type OTHER

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

Hearing Aid - Variation #1 under Program 4

Intervention Type OTHER

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

Unaided

Intervention Type OTHER

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

Interventions

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Hearing Aid - Standard Curve under Program 1

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

Intervention Type OTHER

Hearing Aid - Variation #1 under Program 1

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

Intervention Type DEVICE

Hearing Aid - Variation #2 under Program 5 - Streaming Only

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

Intervention Type OTHER

Hearing Aid - Variation #3 under Program 5 - Streaming Only

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

Intervention Type OTHER

Hearing Aid - Variation #4under Program 5 - Streaming Only

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

Intervention Type OTHER

Hearing Aid - Standard Curve under Program 2

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

Intervention Type OTHER

Hearing Aid - Variation #1 under Program 2

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

Intervention Type OTHER

Hearing Aid - Standard Curve under Program 3

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

Intervention Type OTHER

Hearing Aid - Variation #1 under Program 3

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

Intervention Type OTHER

Hearing Aid - Standard Curve under Program 4

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

Intervention Type OTHER

Hearing Aid - Variation #1 under Program 4

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

Intervention Type OTHER

Unaided

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinyu Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Sonova - Kitchener

Kitchener, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 32976346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30461418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29466265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7963011 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 30803400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25690777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20724358 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-12972

Identifier Type: -

Identifier Source: org_study_id

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