By Craig W. Newman, PhD, and Sharon A. Sandridge, PhD

Sound therapy combined with ongoing counseling and patient education has been the mainstay of audiologic management for patients with bothersome tinnitus. In fact, the American Academy of Otolaryngology — Head and Neck Surgery’s recently published clinical practice guideline recommends the therapeutic use of sound as a method for providing tinnitus relief. Sound therapy can reduce the negative health-related quality of life consequences associated with tinnitus, including sleep disturbance, anxiety, depression and concentration difficulty. In Cleveland Clinic’s Audiology Research Laboratory, we conducted an initial study of a new tinnitus treatment device (TTD) that offers novel and customized sound therapy options.

Traditionally, ear-level sound generators (SGs) that emit broadband noise have been used to promote habituation via both total and partial masking approaches. Currently available SGs, however, are limited by the types of sounds they produce, mainly a broadband white noise. Many patients feel that the white noise is more intrusive than the tinnitus, which compromises any short- and long-term benefit of using SGs.

Creating an auditory ‘scene’

In the Audiology Research Laboratory, we evaluated a first-generation combination (SG and hearing aid) TTD that produces sounds other than white noise. The TTD, which is manufactured by Sanuthera, Inc., consists of two ear-level devices and a small body-worn control unit (Figure 1). The control unit contains a wireless transmitter that interfaces with the ear-level devices and a flash memory that stores a library of sound files from which the patient can select.

The acoustic properties of the sounds incorporate dynamic proprietary temporal (timing) and spectral (frequency) characteristics, as opposed to the static broadband white noise that is used in traditional formats. The therapeutic acoustics include sounds of nature such as waterfalls and ocean waves, as well as “night sounds.” Each sound was engineered beyond its acoustic characteristics to produce an auditory “scene” — that is, a familiar “place” to take the listener away from his or her tinnitus.

Moderate to large treatment benefits

A total of 17 patients with bothersome tinnitus have completed our initial evaluation of the TTD. Results were quantified with two standardized quality-of-life questionnaires: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These two instruments were used as the primary outcome measures to evaluate the impact of the TTD on the patient’s quality of life. The THI and TFI were completed at baseline (prior to device fitting and programming) and at three weeks, two months and six months post-fitting. Calculations of effect size (Cohen’s d) were used to evaluate responsiveness, as determined by a psychometric assessment of treatment-related changes in performance over time. The TTD produced moderate to large treatment effects, with the Cohen’s d value ranging from 0.77 to 1.15 on the THI and 0.77 to 0.89 on the TFI (Table).

Participants evaluating the device commented that the sounds were “soothing” and “helped to draw attention away from the tinnitus.” When used in conjunction with appropriate counseling, these soundscapes hold promise as a pleasant and more acceptable option to the traditional white noise that is used for masking and habituation sound therapy.

This clinical study is representative of the primary mission of our Audiology Research Laboratory, which is to conduct research that is ecologically valid and of practical application so that our findings can be implemented into daily practice.

Clinical benefits of sound therapy in the management of tinnitus

• Provides immediate soothing relief for many patients
• Promotes habituation, thereby reducing negative emotional consequences
• Helps patients control their tinnitus rather than being controlled by it
• Acts to distract the patient from his or her tinnitus by serving as either a background sound or an interesting sound
• Allows some patients to experience residual inhibition (i.e., tinnitus suppression following external sound stimulation)
• Offers a noninvasive approach with no adverse side effects

Dr. Newman is Section Head of Audiology and Co-Director of the Audiology Research Laboratory in the Head & Neck Institute. He can be reached at 216.445.8520 or newmanc@ccf.org. Dr. Sandridge is Director of Clinical Audiology Services and Co-Director of the Audiology Research Laboratory in the Head & Neck Institute. She can be reached at 216.445.8517 or sandridges@ccf.org.