Clinical trial NCT05828017: Investigating Hearing Aid Frequency Response Curves 2
Official title: Investigating Hearing Aid Frequency Response Curves 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Keywords: Hearing Loss
Hearing Aids
Frequency Response Curves
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sound Quality Ratings - Listening Comfort - Program 1
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Overall Preference - Program 1
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Speech Clarity - Program 1
timeFrame: 10 minutes
measure: Sound Quality Ratings - Noise Intrusion - Program 1
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Listening Comfort - Program 2
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Overall Preference - Program 2
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Noise Intrusion - Program 2
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Listening Comfort - Program 3
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Overall Preference - Program 3
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Speech Clarity - Program 3
timeFrame: 10 minutes
measure: Sound Quality Ratings - Noise Intrusion - Program 3
timeFrame: 10 Minutes
measure: Sound Quality Ratings - Overall Preference - Program 4
timeFrame: 10 Minutes
Secondary outcomes:
measure: US Matrix Test in Noise Results - dB SNR 50%
timeFrame: 30 Minutes
measure: Sound Quality Ratings - Streaming
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Sonova - Kitchener
state: Ontario
Study officials:
affiliation: Sonova AG
name: Jinyu Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.