Hearing Loss
Conditions
Brief summary
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.
Interventions
DEVICERoger microphone
Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.
DEVICEPhonak Audeo hearing aid
Commercially available receiver-in-canal hearing aid
Sponsors
Hearts for Hearing
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level) * experienced hearing aid users * symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies) * good written and spoken English language skills * healthy outer ear as confirmed by otoscopy
Exclusion criteria
* contradictions to medical device noted upon otoscopy * known hypersensitivity or allergy to materials of investigational device or comparator * inability to produce reliable test results * known psychological problems * self reported symptoms of dizziness or vertigo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility in Noise | Day 1 of a one day study | The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Participants with bilateral moderate to severe sensorineural hearing loss
Roger microphone: Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.
Phonak Audeo hearing aid: Commercially available receiver-in-canal hearing aid | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | — |
| Age, Continuous | 74 years | — |
| Bilateral Moderate to Severe Sensorineural Hearing Loss | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 Participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Speech Intelligibility in Noise
The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.
Time frame: Day 1 of a one day study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Speech Intelligibility in Noise | Percentage of words correctly repeated with hearing aid only at 0 dB SNR | 58 percentage of words correctly repeated | Standard Deviation 26 |
| Experimental | Speech Intelligibility in Noise | Percentage of words correctly repeated with Roger system at 0 dB SNR | 80 percentage of words correctly repeated | Standard Deviation 20 |
| Experimental | Speech Intelligibility in Noise | Percentage of words correctly repeated with hearing aid only at -5 dB SNR | 27 percentage of words correctly repeated | Standard Deviation 17 |
| Experimental | Speech Intelligibility in Noise | Percentage of words correctly repeated with Roger system at -5 dB SNR | 50 percentage of words correctly repeated | Standard Deviation 23 |
| Experimental | Speech Intelligibility in Noise | Percentage of words correctly repeated with hearing aid only at +5 dB SNR | 80 percentage of words correctly repeated | Standard Deviation 22 |
| Experimental | Speech Intelligibility in Noise | Percentage of words correctly repeated with Roger system at +5 dB SNR | 87 percentage of words correctly repeated | Standard Deviation 17 |
Comparison: Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at 0 dB SNRp-value: <0.01t-test, 2 sided
Comparison: Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at -5 dB SNRp-value: 0.031t-test, 2 sided
Comparison: Speech intelligibility will be equal or better with hearing aids plus Roger device than with hearing aids alone when tested using standardized speech test at +5 dB SNR.p-value: 0.046t-test, 2 sided