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

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

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

Study Overview

• Status: Terminated
• Conditions: Tinnitus
• Intervention / Treatment: Device: Erchonia HLS

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Kathy Amos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erchonia HLS; 635 nanometers (nm) laser application	Device: Erchonia HLS; 56 procedure administrations with the Erchonia® HLS™ administered by the subject at home: daily procedure administrations for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Erchonia Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): March 14, 2022
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: R-Tinnitus-Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No