Brief Title
Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
Official Title
The Effects of the Erchonia Hearing Laser on Word Recognition in Hearing Impaired Individuals Clinical Study Protocol
Brief Summary
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.
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
Primary Outcome
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.
Condition
Sensorineural Hearing Loss
Intervention
The Hearing Laser
Study Arms / Comparison Groups
The Hearing Laser
Description: Active low level laser light therapy of 635 nanometers (nm)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
80
Start Date
August 2007
Completion Date
June 2008
Primary Completion Date
June 2008
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Betty McNamara, M.S., CCC-A, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00787189
Organization ID
EHL-001
Responsible Party
Sponsor
Study Sponsor
Erchonia Corporation
Study Sponsor
Betty McNamara, M.S., CCC-A, Principal Investigator, Maryjane Rees Language Speech & Hearing Center
Verification Date
May 2021