As of February 2022, a total of 162 authors had published 75 relevant articles in 44 different journals. Among the 162 authors, 46 (28.4%) were lead authors. In addition, there were an average of 0.11 (SD 0.98) relevant articles per journal per year and an average of 0.46 (SD 1.27) articles per author. The evolution in the annual number of relevant studies published over the years is shown in Multimedia Appendix 3. With regard to the 75 articles included in this study, there was an overall increasing trend in the annual number of literature publications. There was an average annual increase rate of 24.46% (SD 0.69%), which resulted in 16 articles published in 2021. This trend demonstrates that an increasing amount of research is being carried out on this topic, indicating the increasing need for research in this field.

There was a substantially increased number of articles published in 2015 and 2021, in comparison with the previous and subsequent years. The authors of the 9 articles published in 2015 were mainly from Sweden and the United Kingdom, accounting for 3 (33%) and 2 (22%) articles, respectively. There were 4 articles by Gerhard Andersson as the lead author, from Linköping University (Linköping, Sweden), whose primary research interests were psychopathology and psychotherapy [14-17]. Of the 16 articles published in 2021, a total of 9 (56%) were from the United Kingdom, including 4 (44%) articles by Eldre Beukes, from Anglia Ruskin University, whose main research interest was audiology.

According to the Bradford law of scattering [18], all publications in a specific field, released during a given period, can be divided into core, related, or peripheral zones, according to the number of articles the zones include. The ratio of the number of publications in the 3 zones is 1:a:a², with the approximate value of a being 5. Core publications account for approximately 1 of 31 of the total number of publications. The core publications were calculated to correspond to the top 2 journals, which accounted for 36% (18/75) of the published articles: the American Journal of Audiology (12/75, 16%) and the Journal of the American Academy of Audiology (6/75, 8%). In 2021, the journal impact factors of these 2 journals were 1.636 and 1.249, respectively, and the journal citation reports divisions were Q4 and Q3, respectively. The remaining publications revealed minor differences in terms of the number of published articles.

There were 162 authors in the included literature. According to the Lotka law [19], which states that authors with >0.749 times the square root of the number of papers published by the most prolific scientists, this study defined authors with >4 publications as high-producing authors, accounting for 9.9% (16/162). As can be seen in Table 1, Andersson G was the most prolific author, with 22 publications.

Next, we performed an analysis of the posting trends from highly productive authors. A graph of the annual posting trends of highly productive authors, based on their annual posting data and yearly citation frequencies, is shown in Figure 4. Here, the size of the circles indicates the annual posting volume, and the color shade indicates the annual citation frequency. Of the 16 most productive authors, 15 (94%) were found to have started focusing on mHealth-based treatments and interventions for tinnitus only after 2015. Of these 15 authors, 9 (60%) started publishing after 2018, and they have produced a steady annual output since then.

The 162 authors in our literature pool were from 15 countries. The top 10 countries (corresponding authors’ countries) are shown in Figure 5. Germany has published the largest number of articles in this field (19/75, 25%) and also has the largest number of international collaborations, followed by the United Kingdom (16/75, 21%) and the United States (12/75, 16%). The numbers of multicountry publications and single country publications for the top 10 high-output countries are shown in Figure 5.

In terms of the software development stages described in the literature, of the 75 papers, 49 (65%) referred to the design stage, 19 (25%) pertained to the clinical validation stage, and 7 (9%) concerned the marketing stage. This distribution reflects the negligible development of software for tinnitus treatment. Preliminary research found that the actual demand for such software was notably high.

Upon further analysis, it was found that 50 (67%) of the 75 papers primarily described treatments that used specific software. Of the remaining 25 studies, 12 (48%) mentioned only internet-based or web-based assessment tools for tinnitus, without any specific treatment associated. Of these 12 publications, 6 (50%) described mobile transient tinnitus assessment, and 4 (33%) used machine learning for predicting tinnitus, whereas 1 (8%) described a repository of tinnitus information, and 1 (8%) described a method for characterizing tinnitus heterogeneity. Of the 50 articles describing treatments, the mentioned treatments were mainly in the categories of cognitive behavioral therapy and sound therapy, with 30 (60%) and 13 (26%) papers, respectively. Of the remaining 7 studies, 1 (14%) included usual service therapy using artificial intelligence (AI) to expose the patient to the tinnitus environment, 1 (14%) used a tinnitus e-plan (an intervention coding method), 1 (14%) used visualized mobile electroencephalogram (EEG) for tinnitus detection, 1 (14%) used meditation (to help patients relieve tinnitus), 1 (14%) used both cognitive behavioral therapy and sound therapy, and 2 (29%) used a game training method related to the localization and perception of a sound source as well as auditory attention.

We compared the stage of software development reported in the literature with the therapies related to the respective software. We found that only a single software using cognitive behavioral therapy and sound therapy was in the market stage. With regard to software in the clinical validation stage, 9 (32%) of the 28 apps used cognitive behavioral therapy tools, 3 (12%) used sound therapy, and 2 (17%) used game training methods related to sound source localization perception and auditory attention. Of the 29 apps described in the literature that were in the design phase, 18 (62%) used cognitive behavioral therapy, 7 (24%) used sound therapy, 1 (3%) used habituation therapy (in which AI exposes the patient to the tinnitus environment), 1 (3%) used meditation, 1 (3%) used visualized mobile EEG, and 1 (3%) used an intervention coding approach.

Mobile tinnitus treatment software is currently in high demand. In this study, 28 apps were identified from software data sources (Figure 2), 4 of which were from software with specific names in the literature. These 28 apps consisted of 18 (64%) iOS apps and 10 (36%) Android apps (Multimedia Appendix 4). Most of these apps were developed by institutions (22/28, 79%); a few were developed by individuals (2/28, 7%). Among the 24 apps obtained from product data, 13 (54%) were medical apps, and 9 (38%) were health apps.

Regarding the software providers, of the 28 apps, 22 (79%) were available on the Apple App Store (China), and 21 (75%) were available on the Apple App Store (United States). In addition, 5 (18%) were available on the Google Play Store, and 5 (18%) were available on the Huawei, Xiaomi, Oppo, and Vivo marketplaces. Software activity can be reflected at the time of listing and at the time of the latest update. After data collection, we found that in 23 (82%) of the 28 apps, time information was complete.

Multimedia Appendix 5 depicts the origin of the software developers. Of the 28 apps, 10 (36%) were developed in the United States, 8 (29%) in China, and 9 (32%) in other countries (n=1, 11% in the United Kingdom; n=3, 33% in Germany; n=3, 33% in Denmark; n=1, 11% in Poland; and n=1, 11% in New Zealand). Of the 28 apps, there was 1 (4%) whose country of origin could not be found. Regarding specific locations, the US software developers hailed from 7 states (3/10, 30% from Minnesota; 2/10, 20% from Texas; 1/10, 10% from Colorado; 1/10, 10% from Wisconsin; 1/10, 10% from California; 1/10, 10% from Florida; and 1/10, 10% from Oregon). Of the 8 software developers based in China, 7 (88%) were from regions within mainland China (n=3, 43% from Beijing; n=2, 29% from Jiangsu; n=1, 14% from Shanghai; and n=1, 14% from Guangdong), and 1 (13%) was from Hong Kong, China.

When analyzing the 28 tinnitus treatment–related apps, this study divided them into three main categories: (1) screening and evaluation, (2) intervention and rehabilitation, and (3) education and information. Of the 28 software programs, 28 (100%) were related to intervention and rehabilitation, 11 (39%) were related to screening and evaluation, and 5 (18%) were related to education and information. Regarding the users of the software, of the 28 apps, 26 (93%) were intended to be used by patients or their families, and 2 (7%) were intended to be used by medical staff. In this study, we considered whether a professional was required to assist patients with the software and found that, in the case of 7 (25%) of the 28 apps, a professional was needed to assist the patient. By contrast, the remaining apps (21/28, 75%) could be used by patients without assistance from a professional.

When analyzing the specific functions of the apps, this study divided them into the following 6 areas: assessment, advice, detection, counseling, treatment, and relief. Of the 28 apps, 6 (21%) were dedicated to patient assessment, 4 (16%) could provide advice based on the actual patient situation, 5 (18%) could perform a preliminary test of the patient’s tinnitus or hearing condition, another 5 (18%) had a web-based counseling function, and 13 (46%) could provide the user with a treatment plan for the different tinnitus conditions. The primary product information is described in Multimedia Appendix 6.

After examining the treatments mentioned in the app descriptions, we found that, of the 28 apps, 7 (25%) used masking therapy, 2 (7%) used habituation therapy, and 2 (7%) used cognitive behavioral therapy. Moreover, of the 28 apps, 1 (4%) used sound therapy, 1 (4%) used neuromusic therapy, 1 (4%) used play therapy and frequency discrimination therapy, 1 (4%) used transcallosal vagus nerve microcurrent stimulation, and 1 (4%) used neuromodulation therapy. The remaining apps (12/28, 43%) did not specify the type of treatment used.

Regarding the validity and reliability of the apps, we found that some of the apps (6/28, 21%) were created by developers in collaboration with specific authorities. The 6 partner organizations are the American Tinnitus Association; the Eye, Ear, Nose, and Throat Hospital affiliated to Fudan University (Shanghai, China); a team of doctors from Tsinghua University (Beijing, China); a team of tinnitus specialists from well-known tertiary hospitals and first-line tinnitus experts; a Canadian team with Food and Drug Administration (FDA)–approved tinnitus rehabilitation core technology; and the University of California (Los Angeles, California, United States).

The number of studies in the field of tinnitus apps has increased yearly, with a rapid growth after 2015 and with the annual publication volume peaking in 2021. The articles were published in journals of moderate quality. Nevertheless, the acceptance rates of articles in the field by top medical journals were low. Of the 75 research articles in this field, 51 (68%) were included in the Web of Science core collection and had an average journal impact factor of 5.12 (spanning between 1.245 and 25.617 in the field of psychotherapy and psychosomatics). The studies were mainly published in the American Journal of Audiology and in the Journal of the American Academy of Audiology, with 18 (n=12, 67% and n=6, 33%, respectively) articles published as of February 2022, representing 24% (18/75) of the total number of articles. Nevertheless, the acceptance rates of articles in this field in top medical journals were poor, with no relevant studies published in the New England Journal of Medicine, The Lancet, the Journal of the American Medical Association, or The BMJ. The annual output of the most productive authors was the highest in 2021. In accordance with the Lotka law, this study identified 16 highly productive authors in the field, all of whom have published consistently in the last 3 years. This suggests that this area is steadily and rapidly growing. The authors were mainly from Germany (19/75, 25%), the United Kingdom (16/75, 21%), and the United States (12/75, 16%), with fewer authors from other countries (27/75, 36%), and only a single author from China (1/75, 1%). Of the 75 articles, 47 (63%) were published by authors from Germany, the United Kingdom, and the United States.

The current hot spot in this field is the research on sound and cognitive behavioral therapy, focusing on the outcomes for the treatment of patients with tinnitus. Thematic map analysis showed that the terms in the second quadrant of the thematic map included cognitive behavioral therapy, sound therapy, and tinnitus treatment outcomes. This indicates that research on cognitive behavioral therapy and sound therapy (with a focus on tinnitus treatment outcomes) is a current hot spot in the field of mHealth-based software interventions for tinnitus treatment. This area of research is well developed, with a focus on the assessment of tinnitus, but its importance is not sufficiently recognized yet. Our results are in agreement with those of relevant studies conducted in recent years [22].

Most of the apps (16/28, 57%) in this field have been newly developed and provide functional support for therapeutic interventions for tinnitus. Nevertheless, software development in this field lacks a research basis. Such software often has high requirements for ancillary apps [23], such as the sound quality and calibration of headphones. Cognitive behavioral therapy relies on professional tinnitus specialists for guidance. By contrast, it is difficult to achieve an accurate grasp of a user’s criteria for the use of such apps with mobile phone sensors or wearable apps alone [24]. As a result, and in comparison with other fields, the number of diagnostic apps is relatively small.

The adoption of apps under development has been poor, with the vast majority of the available apps used in very few or no real-life scenarios. The results showed that only 28 designed apps were available for download from app stores. This limitation suggests that, although many tinnitus treatment–related apps have been developed by experts and academics in recent years, most of them still lack practical use. It also suggests that these apps have a very homogeneous collection of patient information and a single-center validation of their effectiveness; in addition, they lack validity studies for clinical retesting as well as user feedback [25]. The reasons behind these aspects could be related to other attributes of the apps, such as their effectiveness and ease of use. To develop and validate apps that can be used in the clinical setting, researchers should also focus on other attributes, such as the ease of use of the apps.

For many years, there has been a lack of translation of the results of tinnitus treatment interventions using mHealth software and apps. This lack of translation is consistent with the results of our study on the analysis of product applications in this area. The vast majority of these apps (22/26, 85%) require both research and development, with scientific validity and effectiveness in a state of urgent need, and are far from truly achieving their goal of an effective tinnitus treatment intervention [26].

With the increased stress levels in modern work and life, tinnitus does not appear in isolation. Nevertheless, it is a combination of symptoms closely related to the etiological mechanisms and aggravating factors of several systemic diseases. More than 50% of patients with tinnitus experience sleep disturbances [32]. In the United Kingdom, the prevalence rate of tinnitus in the adult population is 10.1%, with the disorder severely affecting the quality of daily life [33]. In the United States, the prevalence rate of tinnitus in adolescents is from 7% to 9%, and in older people, it is approximately 25% [34]. In Japan, the prevalence rate of tinnitus in the adult population is 11.9% [35]. Although there are no large-scale epidemiological data on the prevalence rates of tinnitus in China, available studies have reported its prevalence rate in the adult population to be approximately 10%. Approximately 5% of the patients with tinnitus seek medical treatment, and approximately 2% of the patients have tinnitus that severely affects their life, sleep, the ability to concentrate and work, and social activities [36]. The complex and heterogeneous etiology of tinnitus as well as its unclear pathogenesis have contributed to the poor treatment outcomes for this disorder. Nevertheless, as industry and technology continue to develop and society ages, the prevalence of tinnitus is gradually increasing, making its early detection, diagnosis, and effective treatment urgent.

The evidence-based guidelines for clinicians managing patients with tinnitus [1] recommend an acoustic therapy approach, in which any sound can be used to alter the perception of, and response to, tinnitus, for the patient’s benefit. This therapy can be performed with environmental optimization devices such as hearing aids, sound generators, and tinnitus hybrid acoustic therapy devices, as well as commonly used devices such as mp3 players, smartphones, and radios. Tinnitus rehabilitation approaches must not disregard the integration of traditional methods with innovative technologies [37]. With the expansion and increased application of the mobile internet in various industries, health care–focused mobile internet technology has been receiving increased interest owing to its rapid development. Therefore, the combination of sound therapy and cognitive behavioral therapy for tinnitus has led to the development of an mHealth app model with this purpose.

To address the ineffectiveness of traditional treatments for tinnitus, one of the 3 most difficult conditions plaguing human health in the otolaryngology field (the other 2 being deafness and vertigo), researchers have been exploring interdisciplinary avenues [38]. The evidence-based guidelines for clinicians managing patients with tinnitus recommend cognitive behavioral therapy for patients with chronic compensatory tinnitus, as well as effective and feasible acoustic treatment options provided by physicians or hearing aids for patients with tinnitus with hearing loss [39]. mHealth is unique in providing behavioral health interventions. One of its scientific theories is cognitive behavioral therapy. The future integration of mHealth for tinnitus treatment and intervention is in line with the recommendations of professional guidelines and has a sound scientific and theoretical basis.

One of the theoretical foundations of mHealth is cognitive behavioral therapy. As of 2016, approximately 500 mHealth apps based on cognitive behavioral theory were available in the Apple App Store and Google Play Store. Current mobile apps are relatively well established in the use of cognitive behavioral therapy interventions in psychosocial health services to relieve anxiety, depression, and stress as well as treat other physical ailments and improve maladaptive behavioral problems (such as eating disorders and substance abuse). As a result, the product experience in mHealth is relatively mature. More than half of all patients with tinnitus have comorbid psychological problems such as anxiety, depression, and sleep disorders [40]. On the basis of the existing experience with mHealth, there is a clear and feasible pathway for adjunctive treatment and intervention in tinnitus.

Our findings regarding mHealth use in mental health, disease management, and health behavior promotion indicate that mHealth apps, combined with cognitive behavioral therapy, were highly effective in reducing tinnitus pain, anxiety, and depression as well as in improving the patients’ quality of life. In 2019, Aazh et al [41] found that the use of cognitive behavioral therapy for tinnitus was more effective when used 8 to 24 times per week for 60 to 120 minutes each time. The treatment could be remotely guided through an mHealth App to accommodate more patients and promote research progress on effective tools for treating tinnitus [42].