Investigating Hearing Aid Frequency Response Curves 2

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Intervention / Treatment: Other: Hearing Aid - Standard Curve under Program 1; Device: Hearing Aid - Variation #1 under Program 1; Other: Hearing Aid - Variation #2 under Program 5 - Streaming Only; Other: Hearing Aid - Variation #3 under Program 5 - Streaming Only; Other: Hearing Aid - Variation #4under Program 5 - Streaming Only; Other: Hearing Aid - Standard Curve under Program 2; Other: Hearing Aid - Variation #1 under Program 2; Other: Hearing Aid - Standard Curve under Program 3; Other: Hearing Aid - Variation #1 under Program 3; Other: Hearing Aid - Standard Curve under Program 4; Other: Hearing Aid - Variation #1 under Program 4; Other: Unaided

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kitchener, Ontario, Canada, N2E 1Y6
      • Sonova - Kitchener

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

Other: Hearing Aid - Standard Curve under Program 1; Our current hearing aids which will be programmed to our standard frequency response curve.; Device: 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.; Other: Hearing Aid - Variation #2 under Program 5 - Streaming Only; Our current hearing aids which will be programmed to our standard frequency response curve.; 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.; 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.; Other: Hearing Aid - Standard Curve under Program 2; Our current hearing aids which will be programmed to our standard frequency response curve.; 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.; Other: Hearing Aid - Standard Curve under Program 3; Our current hearing aids which will be programmed to our standard frequency response curve.; 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.; Other: Hearing Aid - Standard Curve under Program 4; Our current hearing aids which will be programmed to our standard frequency response curve.; 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.; Other: Unaided; No hearing aids worn at all and participants tested as is.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sound Quality Ratings - Listening Comfort - Program 1	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.	10 Minutes
Sound Quality Ratings - Overall Preference - Program 1	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.	10 Minutes
Sound Quality Ratings - Speech Clarity - Program 1	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. 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). Higher 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.	10 minutes
Sound Quality Ratings - Noise Intrusion - Program 1	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. 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). Higher 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.	10 Minutes
Sound Quality Ratings - Listening Comfort - Program 2	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.	10 Minutes
Sound Quality Ratings - Overall Preference - Program 2	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.	10 Minutes
Sound Quality Ratings - Noise Intrusion - Program 2	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. 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). Higher 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.	10 Minutes
Sound Quality Ratings - Listening Comfort - Program 3	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.	10 Minutes
Sound Quality Ratings - Overall Preference - Program 3	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.	10 Minutes
Sound Quality Ratings - Speech Clarity - Program 3	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. 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). Higher 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.	10 minutes
Sound Quality Ratings - Noise Intrusion - Program 3	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. 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). Higher 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.	10 Minutes
Sound Quality Ratings - Overall Preference - Program 4	Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) 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). Higher 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.	10 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
US Matrix Test in Noise Results - dB SNR 50%	Oldenburg Sentence Test (OLSA) sentences were presented to participants while they were aided under the standard curve, aided under variation #1 frequency response curve, and unaided. Participants are presented with sentences from a loudspeaker placed Infront of them and noise from 7 loudspeakers placed around them (8 speakers placed 30 degrees apart from each other). Participants were asked to repeat what they heard. Correct repetition results in the next sentence to be presented at a lower sound level. Incorrect repetition results in an increase in presentation level for the next sentence. 20 sentences are presented for each condition (i.e., unaided, aided with the standard curve, and aided with the proposed frequency response curve). decibel signal to noise ratio (dB SNR) at 50% correctness scores were calculated at the end and compared amongst the three conditions. There are no minimum or maximum values, however lower scores indicate better performance.	30 Minutes
Sound Quality Ratings - Streaming	Participants will be asked to listen to various streamed stimuli via headphones. They will be asked to toggle between three programs (standard curve, variation #2, and variation #3) and determine which one they prefer the most, which one the prefer the least, and which one they prefer in the middle. 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 was constantly the most preferred across the various stimuli. Highers rankings will indicate that the program was preferred more than the other program and lower rankings mean the program was not preferred when compared to the other program.	1 hour

Collaborators and Investigators

• Sponsor: Sonova AG
• Investigators: Principal Investigator: Jinyu Qian, PhD, Sonova AG

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hearing Loss; Hearing Aids; Frequency Response Curves
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID Numbers: SRF-12972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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