Clear Tinnitus®, Middle-Ear Pressure, and Tinnitus Relief: A Prospective Trial
Barbara Goldstein,1,3 Abraham Shulman,1,3 and Matthew J. Avitable2
1Department of Otolaryngology, Health Science Center at Brooklyn, and 2Scientific
Computing Center, State University of New York, Downstate Medical Center, Brooklyn,
and 3Martha Entenmann Tinnitus Research Center, Inc., Forest Hills, NY
Abstract:
Goal. Our goal was to establish the efficacy, in a 12-week period,
of Clear Tinnitus for tinnitus relief in patients with tinnitus of the severe, disabling
type. Hypothesis. We hypothesized that tinnitus relief with Clear Tinnitus reflects
improvement in the sensory component of the tinnitus complaint by controlling the
factor of aeration of the middle ears and improving eustachian tube function. Method.
In a prospective clinical trial of a homeopathic preparation—Clear Tinnitus—we attempted
to identify in 15 tinnitus patients (14 male, 1 female; mean age, 47.6 years) its
clinical efficacy for establishing tinnitus relief for a 3-month period. We employed
a descriptive data analysis method across dimensions of risk to evaluate a base
of multidimensional evidence and establish support for our hypothesis. A medical-audiological
tinnitus patient protocol completed by each patient identified the clinical type
of tinnitus as predominantly cochlear, with a central and middle-ear component bilaterally.
We identified fluctuation in middle-ear pressure (MEP) via patients’ clinical history,
supported by physical examination and established with tympanometry, as a factor
influencing the clinical course of the tinnitus in each patient. Results. Eleven
of 15 patients completed the study. Seven responders reported tinnitus relief; four
did not respond. Descriptive data analysis failed to detect any trends in a change
in response with audiometric tests across the hearing spectrum; thus, we could derive
no coefficients of hearing change. Evaluation revealed high-frequency tinnitus in
11 patients. The Feldmann masking curve comparison at the start and end of the study
showed no significant change in the 11 patients. There was no significant alteration
in the minimum masking levels or loudness discomfort levels before and after the
study. Tympanometry and MEP measurement indicated a significant difference in MEP
with an improvement on average of -58.18 in the right ear and -40.90 in the left
ear for the 11 patients. Quantitative electroencephalography analysis revealed a
marked difference in the number of significant abnormal recordings between the different
frequency bands, with the delta band significantly higher than the theta, alpha,
and beta bands for both the overall cohort of patients (n = 11) and those reporting
tinnitus relief (n = 7). The tinnitus outcome questionnaires—the tinnitus intensity
index, the tinnitus annoyance index, and the tinnitus reaction questionnaire—revealed
a significant difference for the patients (7 of 11) obtaining tinnitus relief. Results
of the tinnitus stress test , the tinnitus handicap index, and the measurement of
depression scale before and after the study were not statistically significant.
Conclusions: Patients who completed the study demonstrated with tympanometry a statistical
and clinical significance in MEP improvement or maintenance of MEP (or both). Patients
with tinnitus of the severe disabling type selected for this study and responding
to Clear Tinnitus reported tinnitus relief accompanied by improvement in or maintenance
of MEP of the middle ears. The statistical and clinical significance of Clear Tinnitus
for establishing tinnitus relief remains to be established with a larger cohort
of tinnitus patients.
Key Words:
Clear Tinnitus; dimension of risk; medical-audiological tinnitus patient protocol;
tinnitus relief; univariate