NCT05343026

Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss

Efficacy of Hearing-aid Treatment on Sound Perception and Residual Hearing Preservation for Patients With Tinnitus and Co-existing Hearing Loss: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Considering the extent to which HAs play a role in sound perception and residual hearing preservation among patients with tinnitus and co-existing HL remains a lack of compelling extensive evidence, investigators designed this single-blind, 6-months randomized, controlled trial with two parallel groups. One is the HA treatment group, and the other is the waiting list control (WLC) group which receives no interventions during this period.

Detailed description

In clinical practice, chronic subject tinnitus poses an important challenge. This condition can negatively affect an individual's emotional and functional well-being. In most cases, tinnitus is highly associated with hearing impairment, particularly in cases of high-frequency sensorineural hearing loss (SNHL). The occurrence of tinnitus in patients with HL is one of the most prevalent sensory disabilities, causing a deleterious effect on patients' lives. Nowadays, the mild to moderate SNHL can be effectively managed with a fitting hearing aid (HA) by providing sound amplification, and several findings suggest that the HA may also be helpful for people with tinnitus. Nevertheless, in terms of the effects of HA use for residual hearing protection for patients with tinnitus and co-existing hearing loss, inadequate attention is still paid by medical personnel, and relevant evidence remains preliminary at this point in time. To assess the full extent of tinnitus patients, investigators need to carry out a series of tests, including hearing assessment and psychometric tests. Pure tone audiometry (PTA) and otoacoustic emission (OAE) tests are used to calculate the average hearing thresholds and the outer hair cell function, while the Tinnitus hazard Index (THI), the Visual Analogue Scale (VAS), the Hospital Anxiety and the Depression Scale (HADs) and the Athens Insomnia Scale-8 (AIS-8) questionnaires were for patients' psychology status. Investigators hypothesize that in patients with tinnitus and hearing loss, HA intervention results in better conditions of tinnitus and lower hearing threshold reduction. Here investigators planned to enroll patients into two groups, the HA and non-HA (served as the control) intervention patients.

Conditions

• Tinnitus, Subjective
• Hearing Loss, High-Frequency

Interventions

Type	Name	Description
DEVICE	Hearing aids	As for screening the hearing and tinnitus testing, the measure typically comprises PTA, SRS, DPOAE, and several widely accepted standardized tinnitus questionnaires, including the THI for tinnitus severity and VAS for tinnitus loudness.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2022-04-25
• Last updated: 2022-04-25