Photobiomodulation with near-infrared laser for tinnitus management: preliminary animal experiments and randomized clinical trials.

This study investigates the effectiveness of photobiomodulation therapy (PBMT) in treating chronic high-frequency tinnitus with the TINI device, a near-infrared (830 nm) laser. The study includes preliminary animal experiments with 28 mice and a randomized controlled trial with 56 participants to examine the functional and molecular changes in the auditory system that PBMT may cause. The animal model used sodium salicylate to induce tinnitus, followed by PBMT, which showed promising reductions in the behavioral evidence of tinnitus and a reversal of tinnitus-associated upregulation of vesicular glutamate transporters 2 expression in the ipsilateral dorsal cochlear nucleus (p < 0.05). In the clinical trial, participants with chronic high-frequency tinnitus received trans-tympanic application of the TINI device. The results did not show a significant difference in tinnitus score at the final time point when compared to the sham group. However, questionnaires revealed significant improvements in tinnitus symptoms and psychological outcomes following treatment with the TINI device compared to before treatment (p < 0.05). These findings suggest that while PBMT has potential benefits, its clinical effectiveness may be unclear due to its complex nature and interaction with other conditions. Further research is required to optimize treatment parameters and gain a complete understanding of the therapeutic potential of PBMT in managing tinnitus.

Photobiomodulation therapy in improvement of harmful neural plasticity in sodium salicylate-induced tinnitus.

Tinnitus is a common annoying symptom without effective and accepted treatment. In this controlled experimental study, photobiomodulation therapy (PBMT), which uses light to modulate and repair target tissue, was used to treat sodium salicylate (SS)-induced tinnitus in a rat animal model. Here, PBMT was performed simultaneously on the peripheral and central regions involved in tinnitus. The results were evaluated using objective tests including gap pre-pulse inhibition of acoustic startle (GPIAS), auditory brainstem response (ABR) and immunohistochemistry (IHC). Harmful neural plasticity induced by tinnitus was detected by doublecortin (DCX) protein expression, a known marker of neural plasticity. PBMT parameters were 808 nm wavelength, 165 mW/cm2 power density, and 99 J/cm2 energy density. In the tinnitus group, the mean gap in noise (GIN) value of GPIAS test was significantly decreased indicated the occurrence of an additional perceived sound like tinnitus and also the mean ABR threshold and brainstem transmission time (BTT) were significantly increased. In addition, a significant increase in DCX expression in the dorsal cochlear nucleus (DCN), dentate gyrus (DG) and the parafloccular lobe (PFL) of cerebellum was observed in the tinnitus group. In PBMT group, a significant increase in the GIN value, a significant decrease in the ABR threshold and BTT, and also significant reduction of DCX expression in the DG were observed. Based on our findings, PBMT has the potential to be used in the management of SS-induced tinnitus.

The effectiveness of two types of low-level laser therapy in patients with persistent tinnitus.

Tinnitus is a perception disorder of sound with no hearing impulse. It is a very common otology complaint that leads to worsening quality of life. The experience of sound is only the product of neural system activity, with no matching mechanical or vibratory activity in the cochlea, and is unrelated to any external stimuli. Low-level laser therapy (LLLT) is a medical treatment of tinnitus that uses low-energy-level lasers or light-emitting diodes to stimulate or inhibit cellular function. The study included nine patients aged 20-68 years with unilateral or bilateral tinnitus. It was a self-controlled clinical trial study on subjective tinnitus. All patients attended the ENT outpatient Department, Rzgari Teaching Hospital, Erbil, Iraq. Two types of low-level laser therapy (LLLT) devices were used for patients. The first tool, a soft laser called a Tinnitool, has a wavelength of 660 nm and a power of 100 mW. The second tool is a Tinnitus Pen, which has a wavelength of 650 nm and a power of 5 mW. Seven females (77.7%) and two males (22.2%) participated in this study during one month. The mean age of the study sample was 44 years, with a standard deviation of 15.59 years. There was a significant improvement in the comparison of both types of therapy low-level laser before and after treatment, which reduced the tinnitus level among patients from 70% before treatment to 59% and 65.50%, respectively, after one month of treatment. A paired t test was applied to assess this difference before and after treatment. LLLT devices can be an effective device tool for the treatment of tinnitus and can reduce the symptoms of annoyance that affect the life of the sufferer.

The effects of photobiomodulation therapy in individuals with tinnitus and without hearing loss.

To verify the effect of photobiomodulation therapy (PBMT) in individuals with chronic tinnitus without hearing loss, 20 patients who met the inclusion criteria were randomly divided into group 1: active low-level laser (LLL) and group 2: equipment without laser (placebo). Upon anamnesis, data collection, and audiological exams, the Tinnitus Handicap Inventory (THI) and the Visual-Analog Scale (EVA) were applied to measure the level of discomfort with tinnitus and the level of discomfort before and after laser treatment. The protocol used included 12 active LLL sessions for group 1 and not active for group 2, varying red and infrared wavelengths. There was a reduction in the disadvantage of individuals with tinnitus after the intervention and between the initial and final sessions, regardless of the intervention, although group 1 showed a greater reduction than group 2, regardless of point in time of assessment and number of session. There was no statistical difference as to group and point in time for the high-frequency audiometry and acuphenometry outcomes. Individuals with chronic tinnitus reduced the complaint, regardless of point in time and group of intervention; however, the group that received PBMT improved the level of satisfaction, regardless of point in time of assessment and number of session.

Effect of adding a supervised physical therapy exercise program to photobiomodulation therapy in the treatment of cervicogenic somatosensory tinnitus: A randomized controlled study.

OBJECTIVES: To evaluate the effectiveness of adding a supervised physical therapy exercise program to photobiomodulation therapy (PBMT) in the treatment of cervicogenic somatosensory tinnitus (CST). METHODS: Forty patients suffering from CST with age 45-55 years were included in the study. They were assigned randomly into 2 groups, 20 per each. (Study group) Group (A) received a supervised physical therapy exercise program in addition to 20 minutes PBMT with a 650-nanometer wavelength and a 5 milliWatt power output, spot size of 1 cm2, and energy density of 6 Joules, 3 sessions per week for 8 consecutive weeks, plus traditional medical treatment. While (control group), group (B) received the same PBMT protocol, 3 sessions per week for 8 consecutive weeks in addition to the traditional medical treatment. Tinnitus visual analog scaling (VAS), tinnitus handicap inventory (THI), and cervical range of motion (ROM) were measured at baseline and after 8 weeks. RESULTS: Mixed MANOVA showed a statistically significant reduction in tinnitus VAS, THI, and a significant improvement in cervical ROM (flexion, extension, right bending, left bending, right rotation, and left rotation) in favor of Group A (P < .05). There was a significant decrease in posttreatment VAS treatment (P > .001) MD [-2.05(-2.68:-1.41)], and THI relative to pretreatment mean difference [-5.35(-8.51: -2.19)] and a significant increase in posttreatment neck ROM in Groups A and B relative to pretreatment neck ROM (P > .001). Flexion range posttreatment MD[3.65(1.64:5.65)], Extension MD [6.55(1.35:11.75)], right bending MD[3.8(2.51:5.08)], left bending MD[1.75(0.19:3.3)], right rotation MD [3.5(1.28:5.71)] and left rotation [2.75(0.67:4.82)]. CONCLUSIONS: Adding a supervised physical therapy exercise program to PBMT showed positive and beneficial effects in the treatment of CST using VAS, THI, and Cervical ROM assessment tools.

Efficacy of photobiomodulation in the management of tinnitus: A systematic review of randomized control trials.

There is a controversy in regards to the efficacy of photobiomodulation (PBM) in the management of tinnitus. The aim was to systematically review randomized controlled trials (RCTs) that assessed the efficacy of PBM (low-level laser therapy) in the management of tinnitus. The focused question was "Is PBM effective in the management of tinnitus?". Indexed databases were searched up to and including June 2020 using different combinations of the following key words: (a) laser; (b) diode; (c) low-level laser therapy; (d) photobiomodulation; (e) tinnitus; (f) medium-level laser; (g) photo-biomodulation; and (h) low-power laser; and RCTs performed on humans were included. Letters to the editor; case reports/series; commentaries; experimental studies and historic reviews were excluded. The risk of bias was assessed using the modified cochrane collaboration tool. The format of the current systematic review was personalized to summarize the appropriate information. Ten RCTs (2 single-blinded and 8 double-blinded) were included. One study reported 30% and 100% resolution of tinnitus using diode and Neodymium-doped Yttrium Aluminum Garnet lasers; respectively. One study reported that PBM was effective in relieving tinnitus for up to 3 months. Eight studies reported that PBM was ineffective in the management of chronic tinnitus. The risk of bias was high; medium and low in 4; 5 and 1 studies; respectively. The effectiveness of PBM in the management of tinnitus remains debatable. Further power-adjusted and well-designed RCTs with long-term follow-up are needed.

A preliminary study on the efficacy and safety of low level light therapy in the management of cochlear tinnitus: A single blind randomized clinical trial.

OBJECTIVES: To evaluate the efficacy and safety of low-level light therapy (LLLT) using new irradiation parameters for chronic unilateral tinnitus with cochlear dysfunction. DESIGN: A single-blind, randomized clinical trial. SETTING: Tertiary-care hospital center. PARTICIPANTS: Participants who had a history of chronic unilateral tinnitus (≥ 3 months) and pure-tone thresholds greater than 15dB (averaged for 3k, 4k, and 6k Hz). MAIN OUTCOME MEASURES: Numerical rating scales (NRS) measuring loudness, duration, and annoyance, the tinnitus handicap inventory (THI), and psychoacoustical matches of tinnitus loudness and minimum masking levels (MML). RESULTS: Thirty-eight participants were received either a 100-mW diode laser at 830-nm (TINI group; n=19) or placebo (sham group; n=19) irradiation through the tympanic membrane. No adverse events were reported during 2 weeks of 10-interventions (20 minutes/day, five days/week). The NRS measuring duration of tinnitus and psychoacoustical matches of tinnitus loudness significantly decreased over times in the TINI group (p<0.05). However, post-hoc analysis revealed that there was no significant decrease of tinnitus among different time points (baseline, during LLLT, immediately after LLLT, and two weeks after LLLT). There was no placebo effect in the Sham group. Participants who improved the duration by at least one point or improved the loudness matches by more than 5 dB SL two weeks after LLLT tended to have worse pure-tone thresholds. It may suggest that further study is needed in patients with worse pure-tone thresholds to evaluate the therapeutic efficacy of LLLT. CONCLUSION: Although this preliminary result is insufficient to support the therapeutic efficacy of new laser device for chronic tinnitus, further study is needed in a large number of selected patients.

Efficacy of Low-Level Laser Therapy in Subjective Tinnitus Patients with Temporomandibular Disorders.

OBJECTIVE AND BACKGROUND: Tinnitus is an apparent sound, perceived in the ear with no stimulus. It has been described as a sound originating from the brain. It affects 17% of the general population. Etiological factors for tinnitus include temporomandibular joint disorders (TMJ, TMD) and Costen's syndrome. The aim of treatment is to eliminate the tinnitus or at least decrease its apparent volume. MATERIALS AND METHODS: In total, 46 patients referred to our department with bilateral subjective tinnitus with TMDs were selected for this study. Low-level laser therapy (LLLT) with an neodymium-doped yttrium aluminum garnet (Nd:YAG) (1064 nm) laser, LLLT with a diode laser (810 nm), and placebo treatment were applied to the patients. There were 15 patients each in the Nd:YAG and placebo groups and 16 patients in the 810 nm diode laser group. LLLT was applied for 10 days, once per day. A visual analog scale (VAS) was used, with values between 0 and 10. VAS scores were recorded before treatment, on the last day of treatment, and 1 month after treatment. The VAS scores were the same on the last day of treatment and 1 month after treatment. The VAS scores before treatment and at 1 month after treatment were compared in a statistical analysis. RESULTS: There were statistically significant differences in the Nd:YAG laser (p = 0.001) and 810 nm diode laser groups (p = 0.005), but no difference in the placebo group (p = 0.065). CONCLUSIONS: Both the Nd:YAG and 810 nm diode lasers were effective for the treatment of subjective tinnitus related to TMDs.

Effect of low-level laser therapy in the treatment of cochlear tinnitus: a double-blind, placebo-controlled study.

Many treatments for chronic tinnitus have been attempted, but the condition remains difficult to cure, especially in the case of cochlear tinnitus. We conducted a prospective, double-blind, placebo-controlled study to assess the effect of low-dose laser therapy on chronic cochlear tinnitus. Our study population was made up of 66 patients-33 who received active laser treatment (case group) and 33 who received inactive dummy treatment (control group). Patients in the laser group received 5 mV with a wavelength of 650 nm for 20 minutes a day, 5 days a week, for 4 weeks. The controls followed the same schedule, but they were "treated" with an inactive device. The degree of tinnitus was evaluated before and after treatment in each group in three ways: (1) the Tinnitus Severity Index (TSI), (2) a subjective 10-point self-assessment scale for tinnitus loudness, and (3) the Tinnitus Evaluation Test (TET). At study's end, we found no statistically significant differences between the case and control groups in the number of patients who experienced a reduction in TSI values (p = 0.589) or a reduction in subjective self-assessment scores (p = 0.475). Nor did we find any significant reductions in the loudness (p = 0.665) and frequency (p = 0.396) of tinnitus as determined by the TET. We conclude that 5-mV laser therapy with a wavelength of 650 nm is no better than placebo for improving hearing thresholds overall or for treating tinnitus with regard to age, sex, environmental noise level, and the duration of tinnitus.

The effectiveness of transmeatal low-power laser stimulation in treating tinnitus.

The aim of this study is to examine the effectiveness of transmeatal low-power laser stimulation (TLLS) in treating tinnitus. This is a prospective, double-blinded, randomized, placebo-controlled trial. Patients with persistent subjective tinnitus as their main symptom were recruited into the study from the outpatient clinics. The recruited patients were randomized into the experimental group or TLLS+ group (patients in this group were prescribed to use TLLS at 5 mW at 650 nM wavelength for 20 min daily and oral betahistine 24 mg twice per day for a total of 10 weeks) and the control group or TLLS- group (patients in this group were prescribed with a placebo device to use and oral betahistine 24 mg twice per day for 10 weeks). All patients were required to answer two sets of questionnaires: the Tinnitus handicap inventory (THI) and visual analogue scales (VAS) symptoms rating scales, before starting the treatment and at the end of the 10-week treatment period. The total score of the THI questionnaire was further graded into five grades, grade 1 being mild and grade 5 being catastrophic. Wilcoxon-signed ranks test and Mann-Whitney test were used to compare and analyze the THI and VAS scores before and after treatment for each group. Changes with p value of <0.05 were considered as statistically significant. Chi square test was used to analyze the change of parameters in categorical forms (to compare between TLLS+ and TLLS-). Changes with p value of <0.05 were considered as statistically significant. Forty-three patients successfully and diligently completed their treatment. It was noted that using any condition of the device, TLLS+ or TLLS-, patient's tinnitus symptoms improved in terms of THI scores (TLLS+, p value = 0.038; TLLS-, p value = 0.001) or VAS scores with a change of at least one grade (TLLS+, p value = 0.007; TLLS-, p value = 0.002) at p value <0.05 significant level. In contrast when TLLS+ group was compared with TLLS- group, no statistically significant result was obtained. In term of VAS scores, there seems to be no statistically significant improvement in patients' annoyance, sleep disruption, depression, concentration and tinnitus loudness and pitch heard between the two groups. Transmeatal low-power laser stimulation did not demonstrate significant efficacy as a therapeutic measure in treating tinnitus.

Trans-canal laser irradiation reduces tinnitus perception of salicylate treated rat.

The aim of this study was to find out the effect of low-level laser therapy (LLLT) on salicylate-induced tinnitus in the rat model. Fourteen Sprague-Dawley rats (8 weeks; 240-280 gm) were divided into 2 groups (study group, control group). Rats of both groups were treated with 400 mg/kg/day of sodium salicylate for 8 consecutive days. Tinnitus was monitored using GPIAS (Gap Prepulse Inhibition of Acoustic Startle) 2 h after first salicylate treatment, and every 24 h during 9 days of treatment. Rats in laser group were irradiated to each ear with wavelength of 830 nm diode laser (165 mW/cm(2)) for 30 min daily for 8 days. During salicylate treatment, rats of study group irradiated with low level laser showed significantly higher GPIAS values throughout the experiment. Therapeutic effect of LLLT is demonstrated in animal tinnitus model by means of GPIAS. Further experimental studies are needed to find possible mechanisms and better methods to improve LLLT efficacy.

Effectiveness of transmeatal low power laser irradiation for chronic tinnitus.

OBJECTIVE: To evaluate effectiveness of 5 mW laser irradiation in the treatment of chronic tinnitus. STUDY DESIGN: Prospective, randomised, double-blind study. METHODS: This investigation included 66 ears in 45 patients with chronic unilateral or bilateral tinnitus. A 5 mW laser with a wavelength of 650 nm, or placebo laser, was applied transmeatally for 15 minutes, once daily for a week. A questionnaire was administered which asked patients to score their symptoms on a five-point scale, before and two weeks after laser irradiation. A decrease of one scale point, regarding the loudness, duration and degree of annoyance of tinnitus, was accepted to represent an improvement. RESULTS: The loudness, duration and degree of annoyance of tinnitus were improved, respectively, in up to 48.8, 57.7 and 55.5 per cent of the patients in the active laser group. No significant improvement was observed in the placebo laser group. CONCLUSION: Transmeatal, low power (5 mW) laser irradiation was found to be useful for the treatment of chronic tinnitus.

Jugulotympanic paraganglioma (glomus tumour) presenting with recurrent epistaxis.

A case is presented where a left jugulotympanic paraganglioma (JTP) extended to the nasopharynx and the patient presented with recurrent epistaxis. Although initial biopsy of an aural polyp had been suggestive of the diagnosis several years previously, the diagnosis was not confirmed until the patient presented with recurrent epistaxis and severe anaemia. To the best of our knowledge, this is the first case reported of such a presentation of JTP.

Transmeatal low-power laser irradiation for tinnitus.

OBJECTIVE: To evaluate effectiveness of 60-mW laser irradiation in the treatment of tinnitus. STUDY DESIGN: Prospective, randomized double-blind study. METHODS: This investigation included 68 ears in 45 patients with disabling unilateral or bilateral tinnitus. The active or placebo laser treatment was administered transmeatally once a week for 6 minutes. Laser irradiation was performed four times during a 4-week period. A questionnaire was administered to evaluate the loudness, duration, quality, and annoyance of tinnitus before and after irradiation. The loudness and pitch match for tinnitus were obtained, and distortion product otoacoustic emissions were also examined. RESULTS: No significant difference was observed between the active and placebo laser groups with regard to outcome of loudness, duration, quality, and annoyance of tinnitus. In one patient who received active laser treatment, acute hearing deterioration occurred after the third irradiation. CONCLUSION: Transmeatal low-power laser irradiation with 60 mW is not effective for the treatment of tinnitus.

[Treatment of tinnitus with low-intensity laser]. / Behandling af tinnitus med lavenergi-laser.

UNLABELLED: This study evaluated the effect of low-power laser in the treatment of tinnitus in a randomized, prospective, double-blind, placebo-controlled trial. The active laser applied 50 mW (cw, 830 nm) over a period of 10 minutes per session. Forty-nine patients were included. The main outcome was measured using psychoacoustical match of tinnitus loudness, Visual Analog Scale (VAS) ratings of subjective loudness, annoyance and attention involved, scores on tinnitus-specific questionnaires, and a number of psychosocial questionnaires. Only few subjects (18%) experienced subjective improvement. There were no statistically significant differences between the effects of the active laser and placebo treatments. CONCLUSION: Low-power laser treatment is not indicated in the treatment of tinnitus. Reports of significant benefits of this treatment in previous studies may be explained by the placebo effect.

The low-power laser in the treatment of tinnitus.

The purpose of this study was to evaluate the low-power laser on the treatment of tinnitus. In a randomized, prospective, double-blind, placebo-controlled trial, either active or placebo low-power laser irradiation was given through the external acoustic meatus of the affected ear towards the cochlea. The active laser applied 50 mW (cw, 830 nm) over a period of 10 min per session. Forty-nine patients with severe, chronic uni- or bilateral tinnitus were studied. The main outcome was measured using psychoacoustical match of tinnitus loudness and pitch, Visual Analogue Scale (VAS) ratings of subjective loudness, annoyance and attention involved, scores on the Tinnitus Handicap Inventory (THI), the Tinnitus Coping Style Questionnaire (TCSQ), and a number of psychosocial questionnaires. The results showed only moderate (18%) subjective improvement with no statistically significant differences between the effects of the active laser and placebo treatments. Also, there were no statistically significant differences in prepost measurements of tinnitus loudness, VAS scores, THI scores, or TCSQ scores for patients treated with active laser compared with those treated with placebo. We conclude that low-power laser treatment is not indicated in the treatment of tinnitus. Reports of significant benefits of this treatment in previous, mostly uncontrolled or single-blinded studies may be explained by the placebo effect.

[Low-power laser in the treatment of tinnitus--a placebo-controlled study]. / Laser niskoenergetyczny w leczeniu szumów usznych--badania porównawcze z placebo.

The present study was performed on 32 patients in order to investigate the effect of low-power laser on their tinnitus. The patients were divided into two groups. One group received laser therapy and the other was given a placebo procedure. The effect was evaluated by the use of visual analogue scales. Within the patient group transiently evoked otoacoustic emissions (TEOAE) were measured before, during and after therapy. No significant difference between laser and placebo was found in annoyance or loudness of the tinnitus and in changes of TEOAE amplitude. These results indicate that there is no relationship between the effect of low-power laser and changes in cochlear micromechanics.

Efficacy of transmeatal low power laser irradiation on tinnitus: a preliminary report.

Thirty-eight patients suffering from tinnitus resistant to several medical therapies for more than 6 months were treated by low power laser irradiation. A 40 mW laser with a wavelength of 830 nm was irradiated via their external auditory meatus toward the cochlea for 9 min once a week, 10 times or more. Patients were asked to score their symptoms on a 5 point scale before and after the treatment for a subjective evaluation of the effect. The results were estimated by the change of the loudness and duration of tinnitus, and the degree of annoyance due to tinnitus. Although only 26% of the patients had improved duration, loudness and degree of annoyance were relieved in up to 58 and 55%, respectively, without major complication. Laser therapy seemed to be worth trying on patients with intractable tinnitus.

[Soft laser therapy in combination with tebonin i.v. in tinnitus]. / Softlasertherapie in Kombination mit Tebonin i.v. bei Tinnitus.

28 patients were treated with soft-laser therapy. Two-thirds of them had suffered from tinnitus for more than six months and had undergone different therapies before. Each patient was treated twelve times, treatment lasting ten minutes. Before therapy six ml of Tebonin were given i.v. Four minutes later, the laser was positioned at a distance of one centimetre from the patients' mastoid. The laser beam was directed two fingers above the mastoid tip aiming at the lateral wall of the contralateral orbit. Before and three weeks after treatment each patient underwent pure tone audiometry and determination of the tinnitus intensity. Patients were asked to score symptoms before and three weeks after therapy. Hearing levels before and after soft-laser therapy did not show any statistic difference. Three weeks after the last treatment, twenty patients denied any change in tinnitus. Two patients felt an improvement of tinnitus and one patient had recovered completely. Five patients remained undecided about the outcome of therapy. To sum up, according to our results, the trial so far failed to show clear benefits of soft-laser therapy for patients suffering from chronic tinnitus.