Hearing Loss
Conditions
Brief summary
The present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). Participants with mild to severe hearing impairment will be fit binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.
Detailed description
Each participant will be asked to wear a set of BTE and RIC hearing aids and complete the Hearing in Noise Test (HINT) aided and unaided. The investigators will be assessing their speech intelligibility in noise for each condition during the same appointment to determine the SNR50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).
Interventions
DEVICEHearing aid
Participants will complete testing aided and unaided. The hearing aids have been fit to compensate for their hearing loss.
Sponsors
Sonova Canada Inc.
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One similar intervention; 2 groups based on hearing aid model.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adults (18+ years) with hearing impairment (N2 - N6 hearing loss). * Healthy outer ear. * Symmetrical hearing loss. * Ability to answer questions and repeat sentences. * Informed consent as documented by signature. * Willingness to wear different style of hearing aids. * Willingness to wear a binaural fitting. * Willingness to wear closed domes. * Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit
Exclusion criteria
* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product). * Limited mobility/not able to come to scheduled visits. * Inability to produce reliable hearing test result. * Visible congenital or traumatic deformity of the outer ear. * History of active drainage from the ear in the previous 90 days. * Abnormal appearance of the eardrum and ear canal. * Acute or chronic dizziness. * Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. * Known psychological problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility Test in Noise | 2 hours appointment | Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from the existing participant local database. The first participant was enrolled on January 10, 2022 and the last participant was enrolled on January 28, 2022.
Pre-assignment details
All 25 participants enrolled met the inclusion criteria established for this study.
Participants by arm
| Arm | Count |
|---|---|
| Experimental All participants are fit with the BTE and the RIC hearing aids and then complete speech intelligibility testing aided and unaided. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 66.36 years STANDARD_DEVIATION 11.87 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 25 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
| Speech Intelligibility in Noise | 1.7 decibels (dB) Signal-to-Noise Ratio STANDARD_DEVIATION 2.4 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Speech Intelligibility Test in Noise
Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.
Time frame: 2 hours appointment
Population: The data for two participants had to be removed from the final analysis. In both cases, the speech intelligibiliy test could not be completed in one or more study conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Speech Intelligibility Test in Noise | dB SNR unaided condition | 0.83 decibel (dB) Signal-to-Noise Ratio | Standard Deviation 3.43 |
| Experimental | Speech Intelligibility Test in Noise | dB SNR aided condition (BTE) | -2.49 decibel (dB) Signal-to-Noise Ratio | Standard Deviation 1.93 |
| Experimental | Speech Intelligibility Test in Noise | dB SNR aided condition (RIC) | -2.74 decibel (dB) Signal-to-Noise Ratio | Standard Deviation 2.13 |
Comparison: The study compared the results between the unaided condition vs. aided condition (BTE)p-value: 0.0001t-test, 1 sided
Comparison: The study compared the results between the unaided condition vs. aided condition (RIC)p-value: 0.0001t-test, 1 sided