Table 1.
Enrollment Criteria
| Inclusion Criteria | Exclusion Criteria |
|---|---|
| Adults (age 18 and 75 years) | Tinnitus amenable to medical or surgical treatment |
|
Moderate to severe tinnitus (THI score >36) |
Subjective complaints of hyperacusis |
| Tinnitus criteria: chronic (>1year), non‐pulsatile, continuous | Loudness discomfort levels (LDL) less than 100 dB SPL on live‐voice testinga |
| Sensorineural hearing loss with subjective impairment | Prior tinnitus treatment |
| Symmetric sensorineural hearing loss amenable to amplification within limits of ReSound combination device | Residence outside a 60‐mile radius of Springfield Illinois |
| Beck Depression Inventory total score >30; endorsing suicide or self‐harm on BDI item #9 | |
| Unwilling to wear prescribed devices, participate in educational counseling, return for follow‐up over 18 months | |
| Currently using hearing aids or use within the preceding 6 months |
a
The exclusion criterion related to hyperacusis and LDL levels was removed with the approval of the Springfield Committee for Research in Human Subjects (SCRIHS) and the funding agency after the first 163 applicants were evaluated.