Investigating Hearing Aid Frequency Response Curves 2

Hearing Loss, Sensorineural Clinical Trial

Official title:

Investigating Hearing Aid Frequency Response Curves 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05828017
• Other study ID #: SRF-12972
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 11, 2023

Study information

• Verified date: September 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 11, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

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.

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 (7)

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. — View Citation

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

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

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. — 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 Ratings - Listening Comfort	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.	30 Minutes
Primary	Sound Quality Ratings - Overall Preference	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.	30 Minutes
Secondary	Speech Reception Threshold (SRT) Scores	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.	30 Minutes