Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus (NoA-Tin)

University of Regensburg (UR)

Status: Completed

Conditions: Tinnitus

Treatments: Device: Notched filtering (verum); Device: No filtering (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT02408575

Uni-Reg-NoA-Tin

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Notched filtering (verum)

Experimental group

Description:

The 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. Intervention: Device: Conventional hearing aid type Carat 7bx with M-Receiver; Adjustment by Connexx 7.3

Treatment:

Device: Notched filtering (verum)

No filtering (placebo)

Experimental group

Description:

Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering Intervention: Device: Conventional hearing aid type Carat 7bx with M-Receiver; Adjustment by Connexx 7.3

Treatment:

Device: No filtering (placebo)