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

NCT05091060 | Terminated Results FDA Device

• 1 other identifier: R-Tinnitus-Pilot
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Erchonia HLS

EXPERIMENTAL

635 nanometers (nm) laser application

Device: Erchonia HLS

Interventions

Erchonia HLS DEVICE

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

Erchonia HLS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older
• Primary language is English

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Kathy Amos

Walnut Creek, California, 94598, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Travis Sammons
• Organization: Erchonia Corporation

tsammons@erchonia.com

3214731251

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: June 10, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: August 30, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)