Hearing Loss
Conditions
Brief summary
Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic. After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.
Detailed description
Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.
Interventions
DEVICELyric Hearing Aid- Experimental Design
Extended wear hearing aid with a fitting modification that is currently not available
DEVICELyric Hearing Aid- Commercially Available
Extended wear hearing aid that is currently available
Sponsors
Sound Relief Tinnitus & Hearing Center
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not know which device they are wearing as these devices are placed deep in the ear canal by a licensed hearing care professional. The devices are designed to stay in the ear 24 hours a day, and can be worn for several weeks or months at a time.
Intervention model description
In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Mild to moderate hearing loss * New hearing aid users with no previous hearing aid experience interested in trying Lyric devices * Must meet Lyric candidacy (see
Exclusion criteria
)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial to Success Rate | Day 30 of study | Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available | 12 |
| Group B Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
Lyric Hearing Aid- Experimental Design: Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Group B | Total | Group A |
|---|---|---|---|
| Age, Customized | 66 years | 64 years | 62 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 13 participants | 25 participants | 12 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 1 / 12 | 1 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
Trial to Success Rate
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
Time frame: Day 30 of study
Population: All participants that were fit with extended wear hearing devices
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Trial to Success Rate | 2 Participants |
| Group B | Trial to Success Rate | 0 Participants |