Table 2.

Table of evidence for the studies concerning self-help devices.

Study	Intervention					Outcome				Results
Author and year	Intervention	Control group	Treatment period	Follow-up	Primary tinnitus outcome measure		Additional outcome measures	Statistical analysis method	Data results		Statistical analysis results	Dropout	Conclusion	GRADEa
Alonso-Valerdi et al [24], 2021	(1) TRTb; (2) TEAEc; (3) ADTd; (4) BBTe; (5) music	No treatment.	2 months (60 min daily)	FU1f: after 1 week; FU2g: after 5 weeks; FU3h: after 8 weeks	THIi		HADSj, audiometry, tinnitus characteristics analysis, and BLk neurophysiological analysis	Identification of ± or 0 effects t test	All negative differences between BL and FUl were statistically significant (P=.009)		29.4% of the TRT group reported diminution of their tinnitus perception, followed by those in TEAE (18.8%), BBT or ADT (14.3%), and music (7.7%) groups.	Dropout: music 6/16, BBTm 4/18, TRT 3/18, TEAE 5/18, ADT 5/18, and control 3/14	TRT most effective sound-based therapy to reduce tinnitus perception for individuals without anxiety. BBT, ADT, and TEAE produced very similar effects.	⊕⊕⊕○
Altissimi et al [25], 2024	TRT with mobile app	TRT with a traditional sound generator.	6 months	FU1: after 3 months of treatment; FU2: after 6 months of treatment	THI		TRT interview: with questions on tinnitus, hearing loss, hyperacusis, classifying gravity, the annoyance, and the effect on the QoLn of tinnitus, using a VASo.	Descriptive data by counts of a mixed-effect model Tukey test	A significant difference in the THI scores was found in category 1 patients between those treated with a sound generator vs app (–14.529, P<.001)		Improvement was found in category 0 patients, both treated with the app and sound generator; conversely, in category 1, significant improvement was seen only for the group using a sound generator.	No dropout	TRT can be delivered to patients with mild tinnitus (class 0) through mobile apps with results comparable to traditional sound generators.	⊕⊕⊕○
Searchfield and Sanders [41], 2022	The digital therapeutic consisted of an app for iPhone or Android smartphone, Bluetooth bone conduction headphones, a neck pillow speaker, and a cloud-based clinician dashboard to enable messaging and app personalization	The control app was a popular self-help passive sound therapy app called WNp Lite.	12 weeks	FU1: midtrial=6 weeks; FU2: postinterevention	TFIq		COSITr, SUSs, MAUQt	ANOVA with 2 groups and 4 repeated measures, intent-to-treat and completer (per protocol) analyses	Mean changes TFI for USLu at 6 (16.36, SD 17.96 points) and 12 weeks (17.83, SD 19.87 points) were clinically meaningful (>13 reduction), the mean changes in WN group were not (6 wk 10.77, SD 18.53 points; 12 wk 10.12, SD 21.36 points)		A statistically higher proportion of USL participants achieved meaningful TFI change at 6 weeks (55%) and 12 weeks (65%) than the WN group at 6 weeks (33%) and 12 weeks (43%).	4/35 USL and 6/36 WN	The USL group demonstrated a higher proportion of responders than the WN group. The usability of the USL therapeutic was similar to the established WN app. The digital polytherapeutic demonstrated significant benefit for tinnitus reduction, supporting further development.	⊕⊕⊕○

^aGRADE: Grading of Recommendations, Assessment, Development, and Evaluation.

^bTRT: tinnitus retraining therapy.

^cTEAE: therapy for an enriched acoustic environment.

^dADT: auditory discrimination therapy.

^eBBT: broad band therapy.

^fFU1: first follow-up moment.

^gFU2: second follow-up moment.

^hFU3: third follow-up moment.

ⁱTHI: Tinnitus Handicap Inventory.

^jHADS: Hospital Anxiety and Depression Scale.

^kBL: baseline.

^lFU: follow-up moment.

^mBBT: Broad band therapy.

ⁿQoL: quality of life.

^oVAS: visual analog scale.

^pWN: white noise.

^qTFI: Tinnitus Functional Index.

^rCOSIT: Client-Oriented Scale of Improvement in Tinnitus.

^sSUS: System Usability Scale.

^tMAUQ: mHealth App Usability Questionnaire.

^uUSL: UpSilent app.