Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms

NCT05374421 | Terminated Results FDA Device

• 1 other identifier: R-EAR-HOME
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by individuals in their own homes.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI)

  The Tinnitus Functional Index (TFI) has been highly recommended to be used in both clinical and research settings for tinnitus measurement (Meikle et al., 2011). The self-report questionnaire, consists of 25 items with a response option on an 11-point Likert scale from 0-10. The calculation of overall TFI score is as follows: (1) Sum all valid answers. (2) Divide by the number of questions for which the sum of the valid answers was based to yield the respondent's mean item score. (3) Multiply by 10 to attain the respondent's overall TFI score (0-100 range). Total TFI score can be categorized as Level of Tinnitus Severity as follows: 0 to 17: Not a problem,18 to 31: Small problem, 32 to 53: Moderate problem, 54 to 72: Big Problem, 73 to 100: Very big problem. A negative (-) change indicates the negative impact of tinnitus on the individual's everyday life has improved (lessened).

  Baseline and 4 weeks

Study Arms (2)

Erchonia® THL™

ACTIVE COMPARATOR

The Erchonia® EVRL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device.

Device: Erchonia® THL™

Placebo Laser

PLACEBO COMPARATOR

The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light.

Device: Placebo Laser

Interventions

Erchonia® THL™ DEVICE

The Erchonia® THL™ is made up of (2) 405-nanometer violet laser diodes mounted in a portable handheld device. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes.

Erchonia® THL™

Placebo Laser DEVICE

The Placebo Laser has the same appearance as the Erchonia® THL™ but does not emit any therapeutic light. The diodes are positioned approximately 4 inches from the skin and applied in a continuous back and forth sweeping motion from the top of the ear down the side of the neck. The treatments will be self-administered by the subject at his or her's place of residence, once per day for 28 days. Each procedure administration lasts 5 minutes per ear, for a total of 10 minutes.

Placebo Laser

Eligibility Criteria

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

You may qualify if:

• Bilateral tinnitus
• Current diagnosis of subjective tinnitus
• No hearing loss or sensorineural hearing loss only
• years of age or older
• Able to read and write English
• Constant tinnitus on-going over at least the past 6 months
• Willing to abstain from other tinnitus-related treatments, except existing hearing aid use, throughout the study duration.
• Tinnitus Functional Index (TFI) total score of 32 to 72 (Moderate to Big Problem)
• Degree of hearing loss is less than 60 dB (Moderate or less)

You may not qualify if:

• Tympanosclerosis
• Meniere's disease
• Acoustic neuromas
• Current and consistent use of ototoxic medications
• Presbycusis
• Thyroid disease
• Skull fracture
• Traumatic brain injury (TBI)
• Depression
• Syphilis
• Retrocochlear tumors
• Conductive hearing loss
• Pregnant, think they might be pregnant, or breastfeeding.
• Open wounds (sores, cuts, ulcers, etc) around ears or neck
• Cancerous growths around ears or neck

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Valley Audiology

Concord, California, 94520, 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: Clinical Affairs Manager
• Organization: Erchonia Corporation

tsammons@erchonia.com

864-531-0064

Study Officials

• Steven Shanks

  Erchonia Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: May 10, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)