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This study investigated the effect of mild gain amplification (8dB covering 1 Hz to 8kHz) as tinnitus treatment for participants with normal hearing and compared these effects with an active placebo condition using hearing aids without amplification in a double-blinded crossover study. 12 participants with normal hearing and chronic tinnitus were included in the study. Two different hearing aid treatments were provided for 3 weeks each: mild gain amplification that provided 8dB gain in the frequency range from 1 Hz to 8 kHz and no amplification, acting as placebo. The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Functional Index (TFI) questionnaire. The effect of the treatment on tinnitus loudness and annoyance were evaluated with a visual analog scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: mild gain amplification: (8dB, 1 Hz to 8 kHz) | Experimental | Device: mild gain amplification from hearing aids Amplification of 8dB from 1 Hz to 8 kHz No noise cancelling activated |
|
| Placebo Comparator: no amplification | Placebo Comparator | Device: hearing aids with no amplification. No noise cancelling activated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid with NR_4 | Device | Amplification of approx. 8dB from 1 Hz to 8 kHz. No noise cancellation activated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Functional Index | Questionnaire assessing tinnitus related distress, consisting on 25 questions that can be answered with likert scale from 0 to 10 where 10 is the most extreme negative value | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus loudness | Psychoacoustic measurement where participants match the loudness of their tinnitus to either a pure-tone or noisy sound. The loudness of the matched tone could be changed in 3 decibel steps. | 3 weeks |
| Tinnitus spectrum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearing Systems Section | Recruiting | Lyngby | Denmark |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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It was based on the method described by Noreña et al. (2002). The stimuli consisted of either 2-second pure tones (first condition) or 2-second one-third octave noise bands (second condition), with center frequencies spanning from 125 Hz to 14 kHz. These sounds were delivered monaurally through headphones to the ear in which tinnitus was perceived as most intense. When tinnitus perception was equal in both ears, stimulation was applied to the ear with the lower average thresholds at high frequencies. All stimuli were presented at an intensity corresponding to the loudness match of a 1 kHz pure tone, but never below 10 dB sensation level (SL).
| 3 weeks |
| Visual Analog Scale - annoyance | Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying" | 3 weeks |
| Visual Analog Scale - loudness | Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud" | 3 weeks |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |