Sensorineural Hearing Loss
Conditions
Keywords
sensorineural hearing loss, tinnitus, word recognition
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.
Interventions
DEVICEThe Hearing Laser
Two 6-minute low level laser light applications to the head/neck/ears region, each one week apart.
DEVICEPlacebo Laser
inactive low level laser light therapy with no therapeutic output
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Participant flow
Recruitment details
40 subjects (80 ears) were recruited across two hearing aid and evaluation test sites from May, 2007 to October, 2008.
Pre-assignment details
4 subjects (8 ears) were disqualified because the word recognition score recorded for study qualification purposes exceeded the upper inclusive limit of 86% words correct. 4 subjects (8 ears) were disqualified because the subject's primary spoken language was not English, which was also a study exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Active Active laser device | 32 |
| Control Placebo laser device | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Active | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 32 Participants | 58 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 0 Participants | 6 Participants |
| Age, Continuous | 78.94 years STANDARD_DEVIATION 5.92 | 76.00 years STANDARD_DEVIATION 9.86 | 77.47 years STANDARD_DEVIATION 8.265 |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 28 Participants |
| Sex: Female, Male Male | 22 Participants | 14 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
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.
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.
Time frame: baseline and one week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active | 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 participants |
| Control | 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. | 2 participants |
p-value: <0.0005Fisher Exact