Hearing Loss, Sensorineural
Conditions
Brief summary
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.
Interventions
DEVICERoger On microphone
Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids
DEVICERoger Select microphone
Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
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 90 Years
Healthy volunteers
No
Inclusion criteria
* Experienced hearing aid users, age 18 or older * Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss * Good understanding of the English language * Health outer ear as confirmed by otoscopy * Informed consent as documented by signature
Exclusion criteria
* Contraindications to the medical device noted upon otoscopy * Known hypersensitivity or allergies to materials of the investigations device or comparator * Inability to produce reliable test results * Known psychological problems * Self reported symptoms of vertigo or dizziness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lateralization Hearing Ability | Day 1 of 1 day study | Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select) |
| Spatial Hearing Ability | Day 1 of 1 day study | Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.
Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 74 years | — |
| 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
Lateralization Hearing Ability
Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)
Time frame: Day 1 of 1 day study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental | Lateralization Hearing Ability | % Correct using Roger On microphone | 71 percent correct responses |
| Experimental | Lateralization Hearing Ability | % Correct using Roger Select microphone | 54 percent correct responses |
Comparison: MANOVA analysis with independent variable being the intervention condition (type of microphone used) and dependent variable being the performance on lateralization task.~Null hypothesis: There will be no statistically significant difference in lateralization test scores between the Roger On and the Roger Select in the experimental group.p-value: <0.05ANOVA
Primary
Spatial Hearing Ability
Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)
Time frame: Day 1 of 1 day study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental | Spatial Hearing Ability | % Correct using Roger On microphone | 48 percentage of words correctly repeated |
| Experimental | Spatial Hearing Ability | % Correct using Roger Select microphone | 42 percentage of words correctly repeated |
Comparison: Independent variable: intervention condition (type of microphone used), Dependent variable: performance on spatial hearing task. Null hypothesis: There will be no statistically significant difference in spatial hearing test scores between the Roger On and the Roger Select in the experimental group.p-value: >0.05ANOVA