Hearing Loss
Conditions
Brief summary
Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.
Interventions
DEVICEReceiver-in-canal hearing instrument
Receiver-in-canal hearing instrument
Sponsors
Sonova AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate sensorineural hearing loss * Adult
Exclusion criteria
* Inability or unwillingness to wear study devices for extended period of time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Satisfaction of Hearing Aid Performance in Noisy Environments | Three months after initial appointment | Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. |
| Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media | Three months after initial appointment | Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Receiver in the Canal Hearing Instrument 3 Month Group of subjects who will get the receiver in the canal hearing instrument for a 3 month period. | 18 |
| Receiver in the Canal Hearing Instrument 6 Month Group of subjects who will get the receiver in the canal hearing instrument for a 6 month period. | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | Receiver in the Canal Hearing Instrument 3 Month | Receiver in the Canal Hearing Instrument 6 Month | Total |
|---|---|---|---|
| Age, Continuous | 73 years | 72 years | 72.5 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 1 / 17 |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 18 | 1 / 17 |
Outcome results
Primary
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time frame: Three months after initial appointment
Population: Participants who answered the question How satisfied are you with the performance of the hearing aids in noisy environments? after 3 months of wearing devices.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiver in the Canal Hearing Instrument 3 Month | Subjective Satisfaction of Hearing Aid Performance in Noisy Environments | 3.86 score on a scale |
Primary
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time frame: Six months after initial appointment
Population: Participants who wore device for six months and answered the question How satisfied are you with the performance of the hearing aids in noisy environments? at the end of the six months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiver in the Canal Hearing Instrument 3 Month | Subjective Satisfaction of Hearing Aid Performance in Noisy Environments | 2.73 score on a scale |
Primary
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time frame: Three months after initial appointment
Population: Participants who wore devices for three months and who answered the question at the end of the 3 months How satisfied were you with the performance of the hearing aid when streaming?
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiver in the Canal Hearing Instrument 3 Month | Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media | 4.67 score on a scale |
Primary
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time frame: Six months after initial appointment
Population: Participants who wore devices for 6 months and who answered the question at the end of the 6 months How satisfied were you with the performance of the hearing aid when streaming?
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiver in the Canal Hearing Instrument 3 Month | Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media | 4.36 score on a scale |