An interventional study of Lyric Hearing Aid- Experimental Design and Lyric Hearing Aid- Commercially Available in Hearing Loss, sponsored by Sonova AG. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
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.
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Sonova AG is the lead sponsor of 82 studies on the registry; 6 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 17 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Device: Lyric Hearing Aid- Commercially Available
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.
Device: Lyric Hearing Aid- Experimental Design · Device: Lyric Hearing Aid- Commercially Available
Extended wear hearing aid with a fitting modification that is currently not available
Extended wear hearing aid that is currently available
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
| Milestone | Group A | Group B |
|---|---|---|
| Started | 12 | 13 |
| Completed | 9 | 10 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 3 | 3 |
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
| Participants | Group A | Group B |
|---|---|---|
| Trial to Success Rate | 2 | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Group B | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Event | Group A | Group B |
|---|---|---|
| discomfortEar and labyrinth disorders | 1/12 | 1/13 |
Participants who met the fitting criteria for the Lyric extended wear hearing device
| Age, Customized(years) | Group A | Group B | Total |
|---|---|---|---|
| Mean | 62 (51 to 77) | 66 (57 to 75) | 64 (51 to 77) |
| Sex: Female, Male(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Female | 3 | 7 | 10 |
| Male | 9 | 6 | 15 |
| Race and Ethnicity Not Collected(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Group A | Group B | Total |
|---|---|---|---|
| United States | 12 | 13 | 25 |
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Sonova AG