N/A
N=64
Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
Sensorineural Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT00787189 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: 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. — 15; 2 participants — p=<0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Hearing Laser (Device); Placebo Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
15; 2 | <0.0005 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00787189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.