An interventional study of Lyric extended wear hearing aid device A and Lyric extended wear hearing aid with fitting modification device B in Hearing Loss, sponsored by Sonova AG. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-12-14.
Sponsored by Sonova AG · Not applicable, Interventional, and Other
Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.
A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 15 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 currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study)
Device: Lyric extended wear hearing aid device A · Device: Lyric extended wear hearing aid with fitting modification device B
Current commercially available extended wear hearing aid
Extended wear hearing aid with fitting modifications
Subjective Questionnaire of Comfort
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
Time frame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Subjective Ratings of Occlusion With Both Devices
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Time frame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
| Milestone | Intervention |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
| Milestone | Intervention |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
| score on a scale | Intervention |
|---|---|
| Comfort Rating of Device A | 0 (0 to 7) |
| Comfort Rating of Device B (investigational device) | 0 (0 to 10) |
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
| score on a scale | Intervention |
|---|---|
| Occlusion Rating with Device A | 0 (0 to 8) |
| Occlusion Rating with Device B (fitting modification) | 0 (0 to 10) |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| First Intervention (Device A in Right Ear and Device B in Left Ear) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Second Intervention (Device B in Right Ear and Device A in Left Ear) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
Experienced hearing aid users
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 68 (34 to 87) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 8 |
| Male | 7 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 15 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data will not be shared
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Sonova AG