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

Tinnitus Clinical Trial

Official title:

Erchonia and InnerScope, Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05091060
• Other study ID #: R-Tinnitus-Pilot
• Status: Terminated
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: March 14, 2022

Study information

• Verified date: August 2023
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Erchonia HLS
56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.

Locations

Country	Name	City	State
United States	Kathy Amos	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Score on the Tinnitus Handicap Inventory (THI).	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).	Baseline and 8 week