Hearing Loss, Sensorineural, Tinnitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEhearing aid amplification
Hearing aid will be fit to prescribed participant hearing loss.
DEVICEhearing aid amplification with an added sound
Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.
Sponsors
State University of New York at Buffalo
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hearing loss * candidate for hearing aid amplification * Bothersome chronic tinnitus (3 months+)
Exclusion criteria
* age less than 18 years * normal hearing * tinnitus presence for less than 3 months * tinnitus not bothersome enough to warrant intervention * non hearing aid candidates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Functional Index Evaluation (TFI) | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
38 participants signed the consent form and met study criteria
Pre-assignment details
38 participants were randomly assigned into one of two groups. Out of the 38 participants, 8 dropped out during the study. There were 2 study groups in this cross-over study, and final numbers were 15 participants in each group.
Participants by arm
| Arm | Count |
|---|---|
| Cross Over Design, 2 Groups of Participants First Group: started with amplification-only as a 1st intervention, and switched to amplification+noiser Second Group: started with amplification+noiser as a 1st intervention, and switched to amplification-only | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Cross Over Design, 2 Groups of Participants | — |
|---|---|---|
| Age, Continuous Group 1 | 62.2 years STANDARD_DEVIATION 9.5 | — |
| Age, Continuous Group 2 | 60.6 years STANDARD_DEVIATION 9.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 Participants | — |
| Sex: Female, Male Group 1 Female | 8 Participants | — |
| Sex: Female, Male Group 1 Male | 7 Participants | — |
| Sex: Female, Male Group 2 Female | 4 Participants | — |
| Sex: Female, Male Group 2 Male | 11 Participants | — |
| TFI Group 1 | 50 points STANDARD_DEVIATION 16.1 | — |
| TFI Group 2 | 36.2 points STANDARD_DEVIATION 19 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 1 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Population: Repeated measures. Participants served as their own control.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amplification-only | Tinnitus Functional Index Evaluation (TFI) | Group 1 | 35.6 units on a scale | Standard Deviation 20 |
| Amplification-only | Tinnitus Functional Index Evaluation (TFI) | Group 2 | 36.2 units on a scale | Standard Deviation 19 |
| Amplification With Added Sound | Tinnitus Functional Index Evaluation (TFI) | Group 1 | 32 units on a scale | Standard Deviation 21.9 |
| Amplification With Added Sound | Tinnitus Functional Index Evaluation (TFI) | Group 2 | 34.4 units on a scale | Standard Deviation 19.7 |
| No Intervention | Tinnitus Functional Index Evaluation (TFI) | Group 1 | 44.8 units on a scale | Standard Deviation 22.2 |
| No Intervention | Tinnitus Functional Index Evaluation (TFI) | Group 2 | 40.4 units on a scale | Standard Deviation 16.5 |