An interventional study of hearing aid amplification and hearing aid amplification with an added sound in Hearing Loss, Sensorineural and Tinnitus, sponsored by Sonova AG. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.
2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 38 is close to 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:
Hearing aid will be fit to prescribed participant hearing loss.
Device: hearing aid amplification
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.
Device: hearing aid amplification with an added sound
Participants will return to their original unaided state.
Hearing aid will be fit to prescribed participant hearing loss.
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.
Tinnitus Functional Index Evaluation (TFI)
Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.
Time frame: TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.
38 participants signed the consent form and met study criteria
| Milestone | Amplification-only, Then Amplification With an Added Sound, Then Intervention Withdrawal | Amplification With Added Sound, Then Amplification-only, Then Intervention Withdrawal |
|---|---|---|
| Started | 18 | 20 |
| Completed | 15 | 15 |
| Not completed | 3 | 5 |
| Withdrew: Protocol violation | 3 | 4 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.
| units on a scale | Amplification-only | Amplification With Added Sound | No Intervention |
|---|---|---|---|
| Group 1 | 35.6 ± 20 | 32 ± 21.9 | 44.8 ± 22.2 |
| Group 2 | 36.2 ± 19.0 | 34.4 ± 19.7 | 40.4 ± 16.5 |
Collected over 10 months (Between Nov 2022 until September 2023).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amplification-only | 0/30 (0%) | 0/30 (0%) | 2/30 (6.7%) |
| Amplification With Added Sound | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) |
| No Intervention | 0/30 (0%) | 0/30 (0%) | 2/30 (6.7%) |
| Event | Amplification-only | Amplification With Added Sound | No Intervention |
|---|---|---|---|
| Body ache after general incidents happening during the trial periodMusculoskeletal and connective tissue disorders | 0/30 | 1/30 | 2/30 |
| Acquired COVIDImmune system disorders | 1/30 | 0/30 | 0/30 |
| Ear infection after swimmingEar and labyrinth disorders | 1/30 | 0/30 | 0/30 |
Group 1 and Group 2 had 15 participants/each.
| Age, Continuous(years) | Cross Over Design, 2 Groups of Participants |
|---|---|
| Group 1 | 62.2 ± 9.5 |
| Group 2 | 60.6 ± 9.1 |
| Sex: Female, Male(Participants) | Cross Over Design, 2 Groups of Participants |
|---|---|
| Group 1 — Female | 8 |
| Group 1 — Male | 7 |
| Group 2 — Female | 4 |
| Group 2 — Male | 11 |
| Race and Ethnicity Not Collected(Participants) | Cross Over Design, 2 Groups of Participants |
|---|
| Region of Enrollment(Participants) | Cross Over Design, 2 Groups of Participants |
|---|---|
| United States | 30 |
| TFI(points) | Cross Over Design, 2 Groups of Participants |
|---|---|
| Group 1 | 50 ± 16.1 |
| Group 2 | 36.2 ± 19.0 |
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Sonova AG