Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus

Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance

Pilot study on safety, tolerability and clinical performance/randomized double-blind active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus Center of Regensburg and groupwise randomized. Control groups are being treated with hearing aids without notch-filter. Patients and raters are blinded, only the coworker, who is programming the hearing aids, is informed about the group assigned.

A Hearing aid with notched amplification filters frequencies in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.

Inclusion Criteria:

• Chronic tinnitus (≥ 6 months)
• Score of ≥ 10 in TQ12 (Goebel und Hiller)
• Mild to moderate hearing loss of at least 20 dB and maximum 70 dB between 250 Hz and 8 kHz
• Tinnitus with tonal character or narrow band noise (< 1 oktave bandwidth)
• Tinnitus frequency ≤ 8 kHz in tinnitus matching
• Written informed consent of the proband
• If therapy with psychoactive substances is necessary, it has to be stable during at least 10 days and should remain constant during study (changes will be documented in the CRF)
• No regular use (8 hours daily) of hearing aids during 3 month before start of study

Exclusion Criteria:

• Objective Tinnitus
• Start of other tinnitus therapies during 3 months before start of study.
• Missing written consent
• Clinically relevant serious internal, neurologic or psychiatric diseases
• Abuse of drugs, medicaments and alcohol up to 12 weeks before start of study
• Other circumstances that object to study inclusion according to the opinion of the investigator