Tinnitus frequency-filtered music therapy aims to restore lateral inhibition to reverse tonotopic reorganization in the auditory cortex. Although the tinnitus-relieving effect of this therapy has been investigated, the results remain controversial. We performed a prospective, randomized, controlled double-blind study to determine the tinnitus-suppressing effect of tinnitus frequency-filtered music therapy.
The study included 90 participants who were randomly categorized into an experimental group that listened to tinnitus frequency-filtered music and a control group that listened to music from which a random frequency was removed. The Tinnitus Handicap Inventory (THI) score and measures of tinnitus loudness, daily awareness, and tinnitus-induced annoyance were evaluated at the initial visit and at 3 and 6 months (final follow-up). The rates of improvement in THI scores in the two groups were also recorded.
All measured variables showed significant improvement in both groups, except the matched tinnitus loudness and minimal masking level. However, no significant intergroup differences were observed in the amount of improvement in THI scores and any other variable. The rates of improvement in THI scores were higher in the control group at 3 and 6 months.
Listening to tinnitus frequency-filtered music reduced tinnitus-induced handicaps; however, this approach was not significantly better than listening to music from which a random frequency was removed.
Tinnitus is a common disorder with prevalence rates of approximately 10% in the general population and 30% in the elderly population. It can have a number of serious negative effects, including psycho-emotional symptoms such as distraction, insomnia, and depression. Therefore, chronic and persistent tinnitus often requires active intervention. However, there is no established treatment for this intractable disease.
Recently, Okamoto, et al. [
This prospective, randomized, controlled double-blind study was performed to comprehensively examine the tinnitus-suppressing effect of TMNMT. Patients in the experimental group listened to tinnitus frequency-filtered (tailor-made notched) music, while patients in the control group were provided with music stripped of a random frequency unrelated to tinnitus pitch.
We performed a prospective, double-blind, randomized, controlled clinical study, in which 90 participants were randomly divided into two groups: the experimental group listened to music stripped of an octave band centred on the frequency corresponding to the individual’s tinnitus pitch, while the control group listened to music stripped of a random frequency unrelated to the tinnitus pitch. The participants provided audio files of their favourite music, which we modified according to the group allocation and then uploaded to their smartphones. The participants were instructed to listen to the modified music files for 2 h daily for 6 months. Hearing function and tinnitus were assessed at enrolment, and after 3 and 6 months. Institutional Review Board of Kangwon National University Hospital reviewed and approved the study protocol (IRB file number: KNUH-2015-11-001-032). The written informed consent was provided by all participants and we performed the study in accordance with Helsinki Declaration.
Participants were recruited in our hospital via posters, and from among tinnitus patients in our clinic from March 2016 to December 2020. The inclusion criteria were as follows: aged between 18 and 60 years, proficiency in using a smartphone, pure-tone average (PTA) threshold between 0 and 70 dB for frequencies of 250 Hz to 8 kHz, chronic pure tone or narrow band tinnitus (duration ≥3 months), unilateral or bilateral tinnitus with the same pitch in both ears, visual analogue scale (VAS) of daily tinnitus awareness ≥50% and a Tinnitus Handicap Inventory (THI) score ≥18. The exclusion criteria were vascular or somatic tinnitus or tinnitus that could be cured by known therapies; hyperacusis or auditory hypersensitivity unsuitable for music therapy; history of taking antidepressants or other psychotropic medications that could affect tinnitus; and inability to cooperate with the research. Subjects were excluded if they received other treatments for tinnitus, including drugs, during the follow-up period, or if they withdrew consent to participate in the study.
Hearing assessment was performed in a double-walled soundproof room. Pure tone air (250 Hz to 8 kHz) audiometry, tinnitus frequency, loudness and minimal masking level (MML) matching were performed. Assessments of the tinnitus characteristics were performed, i.e., the THI and VAS of subjective tinnitus loudness, daily awareness and annoyance of tinnitus.
The tinnitus pitch was decided in two-alternative forced choice procedure: two frequencies of pure tones (or narrow band sounds) were presented for patients to choose the most similar sound to their tinnitus. In the order of 500 Hz/4 kHz pair, then 250 Hz/500 Hz pair or 4 kHz/8 kHz pair and so on, patients repeated the forced selection procedure in half-octave steps. The above procedure was repeated three times until the final frequency was decided.
We defined THI score as the principal outcome measure because the total THI score could more comprehensively represent tinnitus-related functional, emotional and everyday life handicaps than other variables such as loudness or awareness of tinnitus. As additional measures, matched tinnitus loudness, MML and VAS scores of subjective tinnitus loudness, daily awareness and annoyance were assessed. All variables were measured at the initial visit, and at 3 and 6 months (final follow-up). In addition, we calculated the incidences of improvement in THI score ≥50% and ≥20% in the experimental and control groups at 3 and 6 months.
The SPSS program (v. 22.0; IBM Corp., Armonk, NY, USA) was used for statistical analyses. The patients’ initial demographic, hearing and tinnitus data and amount of improvement at 3 and 6 months (calculated as the difference between the initial and final values) in each variable were compared. Mann–Whitney U-test and chi-square test were applied for continuous and nominal variables, respectively. The amounts of improvement at 3 and 6 months were compared between the two groups using the paired t-test.
Ninety volunteers were initially enrolled in the study, with 41 and 33 continuing for 3 months, and 14 and 15 continuing for 6 months, in the experimental and control groups, respectively. We observed no significant difference in any initial demographic, hearing or tinnitus characteristic between the two groups (
There were no differences in the amounts of improvement in any variables between the two groups including THI scores: 12.0±13.4 vs. 16.7±15.1 and 14.8±12.4 vs. 18.5±14.5 at 3 and 6 months, respectively (
The developers of TMNMT, Okamoto and Pantev, reported that it could reduce the awareness and loudness of tinnitus, and thus help alleviate the suffering of patients. In addition, they reported normalisation of tinnitus-related auditory cortical evoked activity (N1m component of the auditory steady-state response [ASSR]) on magnetoencephalography after listening to notched music, even for only 5 days [
In this study, we assessed changes in tinnitus at 3 and 6 months and observed no differences between the TMNMT and control groups at either time point. In addition, the incidence of THI improvement was higher in the control group at both 3 and 6 months (
A Cochrane meta-analysis reviewed 590 studies on tinnitus-relieving effect of sound therapy (using hearing aids and/or sound generators) and concluded, “There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device [
In the study by Atipas, et al. [
In conclusion, the mechanism of tinnitus-frequency filtered music therapy (TMNMT) is unproven (recovery of tonotopic reorganization), and the developers’ studies used an inadequate neurological marker for tinnitus activity (N1m component of ASSR). Moreover, the results were inconsistent even in their own studies, and there is no reliable evidence of the effectiveness of TMNMT for the treatment of tinnitus. Music therapy, a unique form of sound therapy, appears to have a potential to relieve tinnitus; however, higher-quality research is needed to develop a more effective methodology that addresses optimized stimulation parameters and duration of treatment, and the best responding tinnitus populations.
None
The authors have no financial conflicts of interest.
Conceptualization: Shinyoung Yoo, Eui-Cheol Nam. Data curation: Shinyoung Yoo, Natalia Yakunina. Formal analysis: Natalia Yakunina. Investigation: all authors. Methodology: all authors. Project administration: Shinyoung Yoo, Eui-Cheol Nam. Resources: Shinyoung Yoo, Eui-Cheol Nam. Software: Natalia Yakunina, Eui-Cheol Nam. Supervision: Eui-Cheol Nam. Visualization: Natalia Yakunina, EuiCheol Nam. Writing—original draft: Shinyoung Yoo, Eui-Cheol Nam. Writing—review & editing: all authors. Approval of final manuscript: all authors
Tinnitus-related variables after 3 and 6 months of TMNMT (n=41 and 33 at 3 months, n=14 and 15 at 6 months in the experimental and control groups, respectively). THI and all VAS scores had improved significantly at 6 months in both groups, whereas matched loudness and MML showed no changes in either group (paired t-test, *
Incidences of ≥20% (A) and ≥50% (B) reductions in THI score at 3 and 6 months of TMNMT (n=41 and 33 at 3 months, n=14 and 15 at 6 months in the experimental and control groups, respectively). The incidence rates of THI improvement were higher in the control group at both 3 and 6 months. THI, Tinnitus Handicap Inventory; TMNMT, tailor-made notched music training.
Initial demographic and audiologic profile of experimental and control groups
Variables | Experimental group (No. of ears) | Control group (No. of ears) | |
---|---|---|---|
Age (yr) | 42.7±14.2 (41) | 42.2±12.3 (33) | 0.205 |
Sex (M:F, %) | 75.6:24.4 | 63.6:36.4 | 0.280 |
Duration of tinnitus (mo) | 37.8±56.7 (39) | 29.2±53.9 (32) | 0.525 |
PTA low | 11.0±5.7 (41) | 9.2±8.2 (33) | 0.470 |
PTA mid | 12.8±7.6 (41) | 11.5±8.3 (33) | 0.090 |
PTA high | 35.2±18 (41) | 25.6±17.6 (33) | 0.379 |
Characteristics of tinnitus | |||
Laterality (R:L, %) | 36.6:63.4 | 54.5:45.5 | 0.191 |
Pitch (kHz) | 6.2±2.2 (41) | 5.3±2.6 (33) | 0.132 |
Matched loudness (dB HL) | 44.2±19.1 (39) | 31.6±15.2 (29) | 0.067 |
MML (dB SL) | 3.4±11.9 (38) | 5.3±13.2 (29) | 0.598 |
VAS loudness | 5.5±1.8 (41) | 5.9±6.5 (33) | 0.188 |
VAS awareness (%) | 63.8±29.6 (41) | 58.9±30.4 (33) | 0.378 |
VAS annoyance | 6.0±2.1 (41) | 5.4±2.4 (33) | 0.623 |
THI score | 38.8±18.4 (41) | 40.1±18.1 (33) | 0.268 |
All continuous variables are expressed as mean± standard deviation. MML, minimal masking level; PTA high, average of the scores at 4 kHz and 8 kHz; PTA low, average of the scores at 250 Hz and 500 Hz; PTA mid, average of the scores at 1 kHz and 2 kHz; THI, Tinnitus Handicap Inventory; VAS, visual analogue scale
Amount of improvement in tinnitus-related variables after 3 months of treatment
Variables | Experimental group (No. of ears) | Control group (No. of ears) | |
---|---|---|---|
Matched loudness (dB HL) | 3.2±13.3 (34) | 0.5±11 (23) | 0.832 |
MML (dB SL) | -1.7±10.1 (33) | -0.1±15.7 (23) | 0.217 |
VAS loudness | 0.8±1.7 (41) | 1.2±5.8 (33) | 0.485 |
VAS awareness (%) | 22.4±30.7 (41) | 27.3±29.6 (33) | 0.248 |
VAS annoyance | 1.1±1.9 (41) | 1.5±2.6 (33) | 0.582 |
THI score | 12.0±13.4 (41) | 16.7±15.1 (33) | 0.578 |
All variables are expressed as mean±standard deviation. MML, minimal masking level; THI, Tinnitus Handicap Inventory; VAS, visual analogue scale
Amount of improvement in tinnitus-related variables after 6 months of treatment
Variables | Experimental group (No. of ears) | Control group (No. of ears) | |
---|---|---|---|
Matched loudness (dB HL) | 2.4±19.2 (14) | -5.2±8.2 (7) | 0.607 |
MML (dB SL) | -3.6±12.6 (14) | 0.9±10.3 (8) | 0.274 |
VAS loudness | 1.4±1.6 (13) | 1.5±1.9 (15) | 0.542 |
VAS awareness (%) | 25.5±32.6 (13) | 23.7±34 (15) | 0.871 |
VAS annoyance | 1.9±2 (13) | 1.6±1.7 (15) | 0.757 |
THI score | 14.8±12.4 (13) | 18.5±14.5 (15) | 0.533 |
All variables are expressed as mean±standard deviation. MML, minimal masking level; THI, Tinnitus Handicap Inventory; VAS, visual analogue scale
Randomized controlled double-blind studies on the tinnitus-relieving effect of treatment
Study | Number of subjects (E/C) | Filtered bandwidth (octave) | Duration of treatment (mo) | Results |
|||||
---|---|---|---|---|---|---|---|---|---|
Questionnaires (THI, THQ, TQ) | Matched loudness | MML | VAS loudness | VAS awareness | VAS annoyance | ||||
Okamoto, et al. [ |
8/15 | 1 | 12 | E>C | |||||
Stein, et al. [ |
40/43 | 0.5 | 3 | E>C (TQ) | ns | E>C | ns | ||
Atipas, et al. [ |
52/52 | 1 | 6 | ns (THI) | ns | ns | ns | ns | |
Present study | 41/33 & 14/15 | 1 | 3 & 6 | ns (THI) | ns | ns | ns | ns | ns |
Pantev group.
>, better results; C, control group; E, experimental group; MML, minimal masking level; ns, no significant difference; THI, Tinnitus Handicap Inventory; THQ, Tinnitus Handicap Questionnaire; TQ, Tinnitus Questionnaire; VAS, visual analogue scale