Hearing Loss, Sensorineural
Conditions
Brief summary
The present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. Participants will include adults with moderate to moderately severe hearing impairment. The participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.
Interventions
DEVICENew hearing aid
Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
Sponsors
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to moderately severe sensorineural hearing loss * Willingness to wear custom hearing instruments during the study. * Age-normal cognition * Ability to attend on-site study visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility in Quiet. | Day 1 and Day 15 | Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words | Day 1 and Day 15 | Speech intelligibility on key words for sentences presented in noise. Noise is presented at a fixed level, and the words are presented at adaptive levels, below and above the noise level. A negative number is better, because it indicates the participant can correctly repeat 50% of the words when the words are below the level of noise. This was done at baseline in the unaided condition on Day 1 of the study, and in the aided condition on Day 15. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental All participants will be fit with the study hearing aid and under go the same testing conditions.
New hearing aid: Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 73 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Speech Intelligibility in Quiet.
Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions.
Time frame: Day 1 and Day 15
Population: It was discovered after data collection that the equipment used in this outcome measure was not functioning properly and the dB level presented was not the dB level that was indicated on the equipment. Therefore, this data was not used and no statistical analysis was done.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental | Speech Intelligibility in Quiet. | Percent correct words repeated, in a quiet condition, unaided | 92.3 percentage of correct responses |
| Experimental | Speech Intelligibility in Quiet. | Percent correct words repeated, aided, in a quiet condition | 90.6 percentage of correct responses |
Secondary
Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words
Speech intelligibility on key words for sentences presented in noise. Noise is presented at a fixed level, and the words are presented at adaptive levels, below and above the noise level. A negative number is better, because it indicates the participant can correctly repeat 50% of the words when the words are below the level of noise. This was done at baseline in the unaided condition on Day 1 of the study, and in the aided condition on Day 15.
Time frame: Day 1 and Day 15
Population: All study participants who were fit with study devices who underwent speech in noise testing in both unaided and aided conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words | dB SNR aided condition | -9.83 dB Signal-to-Noise Ratio | Standard Deviation 1.74 |
| Experimental | Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words | dB SNR unaided condition | -5.87 dB Signal-to-Noise Ratio | Standard Deviation 2.87 |
p-value: <0.001t-test, 2 sided