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

NCT ID: NCT05091060

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-03-14

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.

Conditions

Tinnitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erchonia HLS

635 nanometers (nm) laser application

Group Type: EXPERIMENTAL

Erchonia HLS

Intervention Type: DEVICE

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

Interventions

Erchonia HLS

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kathy Amos

Walnut Creek, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R-Tinnitus-Pilot

Identifier Type: -

Identifier Source: org_study_id