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van CCT (UK)

van CCT (UK)

Hearing Aids as a Treatment for Tinnitus in Mild Hearing Loss.

- candidate number6443
- NTR NumberNTR2001
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2009
- Secondary IDs2009.258 METC UMGC
- Public TitleHearing Aids as a Treatment for Tinnitus in Mild Hearing Loss.
- Scientific TitleHearing Aids as a Treatment for Tinnitus in Mild Hearing Loss.
- hypothesisHearing aid fitting will reduce the tinnitus burden in patients with mild hearing loss.
- Healt Condition(s) or Problem(s) studiedTinnitus, Hearing aid, Mild hearing loss
- Inclusion criteria1. Adults (>18years);
2. Tinnitus complaint;
3. Symmetric hearing loss (threshold >= 20dB on 2 and/or 4kHz);
4. A pure tone average threshold = PTA 1-2-4kHz <35dB.
- Exclusion criteria1. An otological condition that needs intervention by an ENT surgeon;
2. A psychiatric condition that needs intervention by a psychiatrist;
3. A non cooperative patient.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2013
- Target number of participants40
- InterventionsA hearing aid is bilaterally fitted. The hearing aid has mild amplification and an open ear-canal fitting.
- Primary outcomeTo evaluate the effect of a hearing aid for the treatment of tinnitus in patients with mild hearing loss and to evaluate the relation with four patient characteristics (see introduction):
1. Amount of hearing loss;
2. Tinnitus frequency;
3. Tinnitus handicap;
4. Psychological distress.

Before, after 6 weeks of use and after 6 months of hearing aid use, the effect is evaluated by a free-field speech audiometry, tinnitus loudness matching and questionnaires to evaluate the tinnitus handicap and a distress.
- Secondary outcomeThe effect of hearing aids will be evaluated on the ability to hear in patients with mild hearing loss.
- Timepoints1. 0 (start);
2. After 6 weeks;
3. After 6 months (end).
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator University Medical Center Groningen (UMCG), dep. of Otorhinolaryngology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryTinnitus is an auditory phantom percept that frequently occurs in combination with hearing loss. It is a potentially devastating condition, that may severely affect daily life. Tinnitus may occur in combination with mild sensory neural hearing loss. Our clinical observations show that in many patients, tinnitus can be surprisingly well reduced by using hearing aids. This seems to be particularly true for mild hearing losses (<35 dB), where a hearing aid would normally not be prescribed. However, the success of using these hearing aids for tinnitus is hard to predict and may be related to several patient characteristics, including the details of the hearing loss. The positive effect of hearing aids on tinnitus has not been systematically studied for mild hearing losses. Also, it is unclear whether hearing aids have a lasting positive effect on tinnitus.
- Main changes (audit trail)
- RECORD10-sep-2009 - 26-okt-2011

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