Debilitating hearing loss (HL) affects ~6% of the human population. Only 20% of the people in need of a hearing assistive device will eventually seek and acquire one. The number of people that are satisfied with their Hearing Aids (HAids) and continue using them in the long term is even lower. Understanding the personal, behavioral, environmental, or other factors that correlate with the optimal HAid fitting and with users' experience of HAids is a significant step in improving patient satisfaction and quality of life, while reducing societal and financial burden. In SMART BEAR we are addressing this need by making use of the capacity of modern HAids to provide dynamic logging of their operation and by combining this information with a big amount of information about the medical, environmental, and social context of each HAid user. We are studying hearing rehabilitation through a 12-month continuous monitoring of HL patients, collecting data, such as participants' demographics, audiometric and medical data, their cognitive and mental status, their habits, and preferences, through a set of medical devices and wearables, as well as through face-to-face and remote clinical assessments and fitting/fine-tuning sessions. Descriptive, AI-based analysis and assessment of the relationships between heterogeneous data and HL-related parameters will help clinical researchers to better understand the overall health profiles of HL patients, and to identify patterns or relations that may be proven essential for future clinical trials. In addition, the future state and behavioral (e.g., HAids Satisfiability and HAids usage) of the patients will be predicted with time-dependent machine learning models to assist the clinical researchers to decide on the nature of the interventions. Explainable Artificial Intelligence (XAI) techniques will be leveraged to better understand the factors that play a significant role in the success of a hearing rehabilitation program, constructing patient profiles. This paper is a conceptual one aiming to describe the upcoming data collection process and proposed framework for providing a comprehensive profile for patients with HL in the context of EU-funded SMART BEAR project. Such patient profiles can be invaluable in HL treatment as they can help to identify the characteristics making patients more prone to drop out and stop using their HAids, using their HAids sufficiently long during the day, and being more satisfied by their HAids experience. They can also help decrease the number of needed remote sessions with their Audiologist for counseling, and/or HAids fine tuning, or the number of manual changes of HAids program (as indication of poor sound quality and bad adaptation of HAids configuration to patients' real needs and daily challenges), leading to reduced healthcare cost.

Objectives: Recently, it has been hypothesized that blood prestin concentration levels may reflect cochlear damage and thus serve as an easily measurable, early sensorineural hearing loss (HL) biomarker. This is a scoping review aiming to identify and critically appraise current evidence on prestin blood levels and their temporal variation in rodents and humans with normal hearing and with sensorineural HL. Design: This study was designed and held according to PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. With no limitation with regards to study type, animal and human studies focusing on prestin blood levels in normal hearing and in sensorineural HL were sought in major databases such as Medline, Central Scopus, PROSPERO, and Clinicaltrials.gov. Results were then hand-searched. A data charting form was developed including the parameters of interest. Results: Seven studies focusing on measuring prestin blood levels by means of ELISA in rodents and human subjects with normal hearing and noise-induced, drug-induced, or idiopathic sudden HL were found eligible and were included in the analysis. According to these proof-of-concept studies, prestin can be detected in the circulation of subjects with no HL; however, normal ranges remain unclear. After cochlear damage, blood prestin levels seem to initially rise and then return to near or below baseline. The degree of their change relates with subjects’ degree of HL, damaged cochlear region and recovery. Prestin blood levels and their temporal variation seem to correlate with cochlear damage; however, methodological weaknesses, such as small sample size, lack of detailed phenotyping, insufficient exclusion of confounding factors, and short follow-up, do not allow for robust conclusions. Conclusions: Current findings support the value of studying blood prestin levels in normal hearing and HL and highlight a need for larger-scale longitudinal research.

Current evidence on efficacy of hearing aids (HAs) on tinnitus perception and annoyance is considered insufficient due to the heterogeneity of tinnitus characteristics and of methods used in the relevant clinical studies. This is a scoping review focused on the methodological aspects of clinical studies evaluating the value of HA fitting as part of tinnitus management over the past 10 years. Thirty-four studies were included in the review, showing important heterogeneity in almost all aspects of inclusion criteria, comparators, outcome measures, follow-up time and HA fitting procedures. Although all studies show that HA fitting has a positive impact on tinnitus perception in patients with hearing loss, the methodological heterogeneity does not allow robust conclusions. Future studies taking into account the different nature and goals of each tinnitus therapeutic modality and adapting their methods, endpoints and timelines according to them could lay the groundwork for obtaining high-quality evidence on whether and how HA fitting shall be implemented in tinnitus management strategies.

Although a wide range of tinnitus management interventions is currently under research and a variety of therapeutic interventions have already been applied in clinical practice, no optimal and universal tinnitus treatment has been reached yet. This fact is to some extent a consequence of the high heterogeneity of the methodologies used in tinnitus related clinical studies. In this manuscript, we have identified, summarized, and critically appraised tinnitus-related randomized clinical trials since 2010, aiming at systematically mapping the research conducted in this area. The results of our analysis of the 73 included randomized clinical trials provide important insight on the identification of limitations of previous works, methodological pitfalls or gaps in current knowledge, a prerequisite for the adequate interpretation of current literature and execution of future studies.

Continuous monitoring of the well-being state of elderly people is about to become an urgent need in the early future due to population aging. Aiming a unified notion of well-being, we find the Intrinsic Capacity concept in accordance with the SMART BEAR project goals. In this study, we mainly focus on the enabling infrastructure, mapping our models to interoperable repositories and to streaming/computing components that can foster monitoring. Our method is also innovative for explicitly combining personalized and risk levels in generating the Intrinsic Capacity score. Leveraging on synthetic data, we represent the outcome trajectories of some sample patients for 1-year continuous monitoring and discuss approaches to characterize them based on the exhibited tendency and evaluate the results from the predictability point of view providing by the entropy of time series concept. At the end, we discuss the possible data quality issues in health care studies using synthetic data.