Randomized Controlled Trial Evaluating Threshold Sound Conditioning in the treatment of Sensorineural Hearing Loss (S26.006)

Abstract

OBJECTIVE: To evaluate safety and efficacy of threshold sound conditioning (TSC) as possible treatment for sensorineural hearing loss. BACKGROUND: Sensorineural hearing loss, an irreversible phenomenon, is one of the most common human disorders, with increasing incidence in elderly patients, severely restricting normal activities and lowering quality of life. However, there are data for central neuronal plasticity and potential for recovery. The introduction of sound conditioning has the potential to activate auditory pathway plasticity and improve basal frequency hearing as measured by pure tone audiometry (PTA). DESIGN/METHODS: Double-blind, randomized, placebo controlled trial of 42 subjects . Data were analyzed using an intention-to-treat design. PTA was performed and hearing thresholds were measured at 8~9 frequencies (0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 KHz) in both ears of each subject, once at baseline, and a second time following TSC intervention. Subjects used a TSC conditioning-enhanced hearing aid 1 hour per day at the hearing threshold level, for 2~3 weeks. RESULTS: Seventy-eight percent of the TSC group showed a significant difference from 44[percnt] in the control group on auditory threshold amelioration; p=0.008091 using ameliorated or mixed change as the dependent variable; and p=0.000546 using ameliorated and mixed combined as a dependent variable by Scheffe’s post hoc test. 77[percnt] of female subjects showed a significant difference in dependent variables from the 47[percnt] of the male subjects; p=0.025468. 75[percnt] of older subjects showed no significant difference from 53[percnt] of the younger subjects; p=0.139149. CONCLUSIONS: TSC outputs an algorithmic acoustic signal with a preset intensity to the frequency band of the damaged hair cell. Previously published human data, and this prospective clinical study demonstrate a statistically significant improvement in a narrow band frequency threshold. These data have important clinical implications as a potential long term therapy for this widespread and growing disability.

Disclosure: Dr. Cho has nothing to disclose. Dr. Kwak has nothing to disclose. Dr. Kwak has nothing to disclose. Dr. Lopez has received research support from Earlogic/The Good Ear Company.