Digital Therapeutics

Hearing-related problems such as hearing loss, tinnitus, and balance problems are some of the most prevalent chronic conditions. Statistics consistently indicate that despite the high incidence rates, many people with distressing hearing-related conditions continue to experience difficulties as they are unable to obtain appropriate help. This may be due to there being no specialized professional available in the geographic area they live; that they have difficulty getting to clinical appointments or cannot afford treatment. This problem is evident to some degree in many countries, even those with good health-care systems. Our vision is to improve access to evidence-based interventions as a way of improving quality of life and helping people actively participate in daily life activities. One way of delivering this is through provision of digital healthcare including internet-based and smart-phone based interventions. Hearing-healthcare is thus brought to the individual in the comfort of their own home instead of in a clinical setting. The value of such interventions is the accessibility but also the ability to provide a standardized and evidence-based interventions. This increases the possibility of the interventions making meaningful differences to the individuals undertaking them and help substantially reduce the disability experienced

The project is centered around (a) intervention development, (b) evaluation of its feasibility, efficacy and effectiveness, and (c) dissemination. This project touches on the research theme 3 (Internet- and mHealth-based interventions) and theme 4 (new service delivery models). Following are the specific studies within this larger project.

Tinnitus is one of the most distressing hearing-related symptoms and are strongly related to having a higher risk of emotional distress, anxiety and depression. Tinnitus is exceptionally difficult to manage due to there being no medical cure to completely eradicate it. Although there are numerous strategies to manage tinnitus, few have proved efficacy. The strategy with the most evidence of effectiveness is known as Cognitive Behavioral Therapy (CBT). Despite this clear evidence, CBT is seldomly offered to individuals with tinnitus. This is often due to a lack of professionals with expertise in tinnitus and CBT. To address this difficulty and internet-based CBT (ICBT) intervention for tinnitus have been developed. We have developed various research themes around these interventions. This includes further development, evaluation and improving accessibility. Initial work involved improved accessibility in terms of improving the interactive nature (Beukes et al., 2016 Internet Interventions), lowering the readability levels required (Beukes et al., 2020 AJA). Although most of the early work was in Europe (Sweden and Germany), we have conducted series of studies in the United Kingdom (Beukes et al., 2018 IJA) and the United States (Beukes et al., 2021 AJA) using the English version of the program. We have also translated the program into Spanish and conducted a global feasibility trial (Beukes et al., 2021 IJA). In addition, we are also working with researchers in India and Turkey to translate and adapt the ICBT program to Kannada and Turkish languages to improve accessibility globally. We have evaluated these interventions extensively in terms of functionality and acceptability (Manchaiah et al., 2020 AJA), feasibility (Beukes et al., 2017 JAAA; Beukes et al., 2021 AJA), efficacy (Beukes et al., 2018 Ear and Hearing), effectiveness (Beukes et al., 2018 JAMA Otolaryngology) and long-term outcomes (Beukes et al., 2018 AJA). We have also compared the outcomes of internet-based applied relaxation and ICBT in a recent dismantling trial (Beukes et al., 2021 Internet Interventions). In recent studies, we have applied various Artificial Intelligence/ Machine Leaning (AI/ML) methods to develop predictive models of ICBT as well as to examine key predictors (Rodrigo et al., 2021 BMJ Open; Rodrigo et al., JMIR).Furthermore, to enable delivery of these interventions we have published a manual aimed at audiological professionals to guide these interventions (Beukes et al., 2021 Plural Publishers) Evidence is accumulating for the benefit of these both in terms of reducing tinnitus difficulties as noted in qualitative studies (Beukes et al., 2018 IJA), process evaluation studies (Beukes et al., 2018 IJA), and in a systematic review (Beukes et al., 2019 Trends in Hearing). Further work is underway to improve the dissemination and availability of these interventions and using different formats including smartphone applications, creating a video-based intervention, and also to apply ICBT in a stepped care model to improve engagement and compliance as well as to reduce cost for implementation.

Study Lead: Eldre Beukes

Vestibular rehabilitation can be instrumental in improving balance disorders and in fall prevention. Provision of vestibular rehabilitation is limited to a few specialized centers from physical therapists and some trained audiological specialists. To improve access to these techniques digital interventions have been developed in recent years. For example, we have developed and evaluated the efficacy of web-based peer-support program for individuals with Ménière’s disease in Finland (Rasku et al., 2015 JMIR Rehabilitation and Assistive Technologies; Pyykkö et al., 2017 IJA; Pyykkö et al., 2017 AJA). In addition, few controlled trials in the United Kingdom and the Netherlands have also demonstrated the efficacy of Internet-based vestibular rehabilitation in reducing dizziness, dizziness-related disability as well as comorbidities such as anxiety and depression. To build on this work we are further developing the materials to adapt to the US population. The aim will be to ensure accessibility, provide guidance, and evaluate efficacy. The longer-term goal will be to translate the intervention to improve dissemination in different countries.

Study Lead: Sidika Cesur

There is a growing number of Direct-to-Consumer (DTC) hearing devices (e.g., Personal Sound Amplification Products [PSAPs]; Over-the-Counter [OTC] Hearing Aids) in the market especially fueled by regulatory changes. These devices are bought by individuals (e.g., online, pharmacies, supermarkets) with hearing loss without consulting hearing healthcare professionals. Although there is growing evidence in efficacy of these devices in addressing some of the consequences of hearing loss, their benefit can be maximized through provision of rehabilitation program (e.g., communication strategies). Previous audiological research has suggested that hearing device is only part of the solution to addressing the communication as well as the psychosocial issues noticed by individuals with hearing loss and that these individuals would benefit from auditory rehabilitation program. Several studies in Sweden have demonstrated that the rehabilitation program to hearing aid users can be administer via the Internet, although no studies exist in the US. Work is thus underway to develop a digital resource to educate those with hearing loss on how to use hearing aids, provide communication tactics and advice on looking after their hearing.

Study Lead: Vinaya Manchaiah

During the last two decades, numerous studies have been published to demonstrate the acceptability, feasibility, efficacy and effectiveness of Internet-based interventions for tinnitus, hearing loss, and balance disorders. We have performed a series of systematic reviews to examine the role and efficacy of Internet-based audiological interventions (Beukes & Manchaiah, 2019 ASHA Perspectives; Beukes et al., 2019 Trends in Hearing)

Study Lead: Eldre Beukes