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Effects of Infrared Light Treatment on Impaired Auditory Function DEE ADAMS NIKJEH, PH.D. JENNIFER J. LISTER, PH.D. STEPHANIE M. TRACIE, B.S. UNIVERSITY OF SOUTH FLORIDA TAMPA, FLORIDA 2009 ASHA CONVENTION NEW ORLEANS, LA RESEARCH ISSUE What we know so far… ¾Current available treatments for sensorineural hearing loss amplify and acoustically modify sound ¾ Hearing aids ¾ Cochlear implants ¾ Assistive listening devices ¾Light therapy systems have been shown to increase blood flow and modulate cellular function ¾Current literature supports a connection between improved circulation and potential for improved hearing RATIONALE ¾ Numerous inner ear pathologies such as sudden deafness, noise-induced HL, Meniere’s disease & sensorineural HL are associated with reduction or alteration of blood flow to cochlea ¾ Light energy influences localized production of nitric oxide (NO) Æstimulates vasodilation Æincreases blood flow RATIONALE ¾ Pulsed photo-energy is noninvasive therapeutic agent for treating soft tissue injuries, severe wounds, and chronic pain due to peripheral neuropathy ¾ Effectiveness depends on absorption by targeted tissue based on wavelength, skin contact, and perpendicular delivery of pulsed light QUESTION ¾Does pulsed infrared light improve hearing among adults with sensorineural hearing loss? ¾Specifically, does performance improve on any objective or subjective component of a comprehensive auditory assessment battery? METHODS ¾ Clinical trial feasibility study in collaboration with Anodyne Therapy System LLC ¾ Anodyne Therapy is a form of Monochromatic Infrared Photo-Thermal Energy (MIRE TM) ¾ ¾ ¾ ¾ U.S. patented and FDA-approved medical device to increase circulation & reduce pain, stiffness & muscle spasm Delivers near infrared (890 nm) photo energy 60 luminous diodes on a flexible pad Placed in direct skin contact to maximize absorption PARTICIPANTS ¾ 30 English speaking adults (ages 55-80) ¾ Bilaterally-symmetrical, high-frequency, sloping, adultonset sensorineural hearing loss ¾ Word recognition scores 70% or less each ear in quiet, 60 dB HL ¾ Negative history ¾ Chronic middle ear disease ¾ Neurological disorder ¾ Cognitive impairment ¾ Hemophilia ¾ Exposure to excessive noise ¾ Exposure to ototoxic agents ¾ Necrotic skin over mastoid processes PROCEDURE – Screening for inclusion ¾ Mini Mental State Examination (MMSE) – Score > 27 ¾ Otoscopic Exam – cursory exam of outer ear and skin behind ear ¾ Pure tone air conduction & bone conduction - 250 to 8000 Hz including 3000 and 6000 Hz ¾ Left ear, right ear, & binaural monosyllabic word recognition in quiet - 50-word NU6 lists, 60 dB HL PROCEDURE – Pre & Post Standard Audiometric Evaluation ¾ Tympanometry & Acoustic Reflex Thresholds ¾ Ipsilateral & contralateral ¾ 500, 1k, & 2k Hz ¾ Speech Reception Threshold (SRT) ¾ Left ear, right ear, & binaural ¾ 50% correct threshold for speech measured using recorded spondee words ¾ Monosyllabic Word Recognition (WRS) in quiet ¾ Left ear, right ear, & binaural ¾ 50-word NU6 lists, 84 dB HL PROCEDURE – Pre & Post Standard Audiometric Evaluation ¾ Monosyllabic word recognition in noise (WIN) ¾ Left ear, right ear, & binaural ¾ Words in Noise (WIN) test ¾ Otoacoustic Emissions ¾ Distortion Product (DPOAEs) ¾ Transient Evoked (TEOAEs) ¾ Patient self-report of communication problems ¾ Abbreviated Profile of Hearing Aid Benefit (APHAB) ¾ Tinnitus Handicap Inventory (THI) PROCEDURE – Treatment Protocol Anodyne Therapy System ¾ Infrared pulsed light treatment ¾ Nine, 30-minute sessions ¾ 3 times/week, 3 weeks ¾ After 4th treatment ¾ NU-6 monosyllabic wd list - word recognition in quiet at 60 dB HL ¾ WIN – words in noise test ¾ After 9th treatment – Repeat audiometric evaluation ANODYNE THERAPY SYSTEM Word Recognition (WRS) Quiet – 60 and 80 dB HL Significant improvement: Right 60 dB (p=0.002) Left 60 dB (p=0.005) No Significant improvement: Binaural 60 dB (p=0.217) All 80 dB conditions (p>0.05) Speech Reception Threshold (SRT) Significant improvement: Left ear (p=0.003) Binaural (p=0.05) No Significant improvement: Right ear (p=0.354) Words in Noise (WIN) Significant improvement: Right ear (p=0.002) No Significant improvement: Left ear (p=0.055) Binaural (p=0.166) Self-Report Measures APHAB & THI Significant improvement: APHAB-EC (p<0.001) APHAB-BN (p=0.002) APHAB-RV (p=0.002) THI (p=0.02) No Significant improvement: APHAB-AV (p=0.83) Clinical Significance Word recognition in Quiet: Relative to pre-test performance (Carney & Schlauch, 2007) Test WRS at 60 dB HL Words in Noise test: SNR improvement of 3.2 or more (Wilson, McArdle, & Smith, 2007) WIN Ear Number of Participants Right 8 Left 4 Binaural 3 Right 4 Left 1 Binaural 3 SUMMARY ¾ Statistically significant treatment effects for several measures of word recognition. ¾ Clinically significant improvement for word recognition in quiet and in noise. ¾ 30% of the participants in at least one ear condition. ¾ Self-reported improvements in ease of communication, even in background noise and reverberation. ¾ Self-reported improvement in tinnitus symptoms ¾ Pulsed infrared light treatment warrants further research