Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

Not Applicable

Terminated

Conditions: Tinnitus

Interventions: Device: Erchonia HLS

Registration Number: NCT05091060

Lead Sponsor: Erchonia Corporation

Brief Summary: This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms

Detailed Description: The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing temporary relief of tinnitus symptoms in adults 18 years and older.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

Inclusion Criteria

Subjective tinnitus
Tonal tinnitus.
Constant tinnitus on-going at least half the time over at least the past 6 months.
Willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration.
Willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation.
18 years of age or older
Primary language is English

Exclusion Criteria

Objective tinnitus
Atonal, pulsatile, intermittent, or occasional tinnitus
Severe or profound hearing loss in one or both ears
Current or prior surgically removed acoustic neuroma
Consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days:

NSAIDS (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates Lasix and other "loop" diuretics "mycin" antibiotics such as vancomycin quinine and related drugs Chemotherapy agents such as cis-platin

Acute or chronic vertigo/dizziness
Ménière's disease
Prior stapendectomy
Prior mastoidectomy
Auditory nerve tumor (acoustic neuroma), current or surgically removed in the past
Active infection/wound/external trauma to the areas to be treated with the laser
Medical, physical or other contraindications for, or sensitivity to, light therapy
Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erchonia HLS	Erchonia HLS	635 nanometers (nm) laser application

Primary Outcome Measures

Name	Time	Method
Total Score on the Tinnitus Handicap Inventory (THI).	Baseline and 8 week	The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual's life. Each question is responded to as 'yes' (4 points); 'sometimes' (2 points) or 'no' (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual's life. Change in total THI score is calculated as total THI score after the eight week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual's everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened).

Secondary Outcome Measures