Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus
NCT ID: NCT02408575
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2015-02-28
2016-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Notched filtering (verum)
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
Notched filtering (verum)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 The Hearing aid with notched amplification filters frequences 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.
No filtering (placebo)
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
No filtering (placebo)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3
No notched filtering
Interventions
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Notched filtering (verum)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 The Hearing aid with notched amplification filters frequences 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.
No filtering (placebo)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3
No notched filtering
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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University of Regensburg
OTHER
Responsible Party
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Berthold Langguth, MD, Ph.D.
Head of Outpatient Clinic
Principal Investigators
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Berthold Langguth, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Regensburg
Locations
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University of Regensburg - Dept of Psychiatry and ENT Dept.
Regensburg, , Germany
Countries
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Other Identifiers
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Uni-Reg-NoA-Tin
Identifier Type: -
Identifier Source: org_study_id