Investigating Hearing Aid Frequency Response Curves

Hearing Loss, Sensorineural Clinical Trial

Official title:

Investigating Hearing Aid Frequency Response Curves

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521308
• Other study ID #: SRF-3167
• Status: Completed
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: January 11, 2023

Study information

• Verified date: January 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Intervention

Device:
• Hearing Aid - Standard Curve
Our current hearing aids which will be programmed to our standard frequency response curve.
• Hearing Aid - Variation #1
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
• Hearing Aid - Variation #2
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
• Hearing Aid - Variation #3
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
• Hearing Aid - Variation #4
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.

Locations

Country	Name	City	State
Canada	Sonova - Kitchener	Kitchener	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sound Quality Rating - Streamed	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	Sound Quality Rating - Live	Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and determine which program they prefer to listen to. Participants will be asked to make ratings in the lab, outdoors, and the cafeteria.; Similar to Outcome 1, 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.	60 minutes