Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

May 26, 2021 updated by: Erchonia Corporation

The Effects of the Erchonia Hearing Laser on Word Recognition in Hearing Impaired Individuals Clinical Study Protocol

The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. Sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. In most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' Current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. Low Level Laser Therapy was first applied for the treatment of inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980's. Hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. Low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of ATP. The resultant surge in ATP production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95818
        • McDonald Hearing Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sensorineural hearing loss.
  • Mild or greater degree.
  • Adult onset.
  • Gradual onset.
  • Hearing loss stable over past 12 months.
  • Etiology of presbyacusis or noise-induced hearing loss.
  • Unaided word recognition score between 28% and 86%.
  • English as primary spoken language.
  • Willing and able to abstain from other treatments or medications to improve hearing ability.
  • Willing and able to abstain from work or other activities that involve loud noise exposure.

Exclusion Criteria:

  • Central auditory processing disorder.
  • Active/recurrent middle ear infection.
  • Meniere's disease.
  • Tympanic membrane perforation/tubes.
  • Cochlear implant.
  • Removal of acoustic neuroma.
  • Hyperacusis/misphonia.
  • Photosensitivity disorder.
  • Active infection/wound in head/ear region.
  • Pregnant/lactating.
  • Serious mental health illness.
  • Significant developmental disability/cognitive impairment.
  • History of drug/alcohol abuse.
  • Involvement in litigation/worker's compensation/disability benefits for hearing loss.
  • Other research participation in past 90 days.
  • Use of ototoxic medications known to cause temporary or permanent hearing loss.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The Hearing Laser
Active low level laser light therapy of 635 nanometers (nm)
Device: The Hearing Laser
Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
Placebo Comparator: Placebo Laser
inactive low level laser light therapy with no therapeutic output
Device: Placebo Laser
inactive low level laser light therapy with no therapeutic output

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.
Time Frame: baseline and one week
Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. The change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.
baseline and one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erchonia Corporation

Investigators

  • Principal Investigator: Betty McNamara, M.S., CCC-A, Maryjane Rees Language Speech & Hearing Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 6, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (Estimate)

November 7, 2008

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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