NCT00787189

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DEVICE	The Hearing Laser	Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
DEVICE	Placebo Laser	inactive low level laser light therapy with no therapeutic output

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-11-07
• Last updated: 2021-05-28
• Results posted: 2011-07-11

Locations

1 site across 1 country: United States