Investigating Hearing Aid Frequency Response Curves 2

Sponsor
Sonova AG (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05828017
Collaborator
(none)
25
1
1
4
6.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing Aid - Standard Curve
  • Device: Hearing Aid - Variation #1
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigating Hearing Aid Frequency Response Curves 2
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: Hearing Aid - Standard Curve
Our current hearing aids which will be programmed to our standard frequency response curve.

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

Outcome Measures

Primary Outcome Measures

  1. Sound Quality Ratings - Listening Comfort [30 Minutes]

    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.

  2. Sound Quality Ratings - Overall Preference [30 Minutes]

    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

  1. Speech Reception Threshold (SRT) Scores [30 Minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sonova - Kitchener Kitchener Ontario Canada N2E 1Y6

Sponsors and Collaborators

  • Sonova AG

Investigators

  • Principal Investigator: Jinyu Qian, PhD, Sonova AG

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sonova AG
ClinicalTrials.gov Identifier:
NCT05828017
Other Study ID Numbers:
  • SRF-12972
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Sonova AG
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2023