Periodic Reporting for period 1 - MOSAICS (Hearing Matters: European Industrial Doctorate to train experts in auditory implants for minimised outcome spread and maximized participation in society)
Periodo di rendicontazione: 2019-10-01 al 2021-09-30
According to the world health organisation (WHO), over 5% of the world’s population require rehabilitation to address their disabling hearing loss. It is estimated that by 2050 over 700 million people – or one in every ten people – will have a disabling hearing loss. Therefore, in 2021 the WHO issued the first WHO Report on Hearing calling for “Integrated people-centred ear and hearing care”. The MOSAICS H2020 MSCA EID project is supporting this call. For the higher degrees of bilateral hearing loss, hearing aids are no longer providing sufficient benefit, and cochlear implants (CI) are the only effective therapy. Cochlear implants are the most successful brain-machine interface devices so far bridging the gap in the auditory pathways created by the loss of inner hair cells in the inner ear. They do this by direct electrical stimulation of the auditory nerve.
However, adoption by adults who would benefit from a CI is low, around 5%. There are many reasons for non-adoption, the variability of hearing outcomes being a major one. Although implants have been proven to be very effective at the group level, there is insufficient consistency of hearing outcomes at an individual level, raising concerns and doubts among patients and additional caution in counselling among clinicians. Hearing outcomes with a CI are the result of a multi-stage process, involving candidate selection, surgery, device fitting and effective auditory training. At any stage, a variety of factors may limit performance. Patient-related factors include the degree of ear-level damage, cognition and supportive environment. Surgical ones relate to the placement of the intracochlear electrode and the atraumaticity of the surgery. The audiologist fits the device creating a better or worse electrode-neural interface and the brain must adjust through training to maximise the use of the new electrical hearing modality – an effortful learning process helped by rehabilitation assisted by a speech and language therapist. In summary, hearing outcomes depend on both the patient’s personal capabilities and the expertise of several professionals. The current state of the art is that the root causes for the variability in performance among CI recipients are poorly understood, with only 25% explained by current clinical prediction factors. Clinicians tend to accept poorer outcomes, not knowing well enough what diagnostics or treatments to propose. MOSAICS has the ambitious goal to augment our understanding of the root causes and to propose effective diagnostics and explore personalised intervention in device fitting and rehabilitation, using a holistic and multidisciplinary approach.
However, adoption by adults who would benefit from a CI is low, around 5%. There are many reasons for non-adoption, the variability of hearing outcomes being a major one. Although implants have been proven to be very effective at the group level, there is insufficient consistency of hearing outcomes at an individual level, raising concerns and doubts among patients and additional caution in counselling among clinicians. Hearing outcomes with a CI are the result of a multi-stage process, involving candidate selection, surgery, device fitting and effective auditory training. At any stage, a variety of factors may limit performance. Patient-related factors include the degree of ear-level damage, cognition and supportive environment. Surgical ones relate to the placement of the intracochlear electrode and the atraumaticity of the surgery. The audiologist fits the device creating a better or worse electrode-neural interface and the brain must adjust through training to maximise the use of the new electrical hearing modality – an effortful learning process helped by rehabilitation assisted by a speech and language therapist. In summary, hearing outcomes depend on both the patient’s personal capabilities and the expertise of several professionals. The current state of the art is that the root causes for the variability in performance among CI recipients are poorly understood, with only 25% explained by current clinical prediction factors. Clinicians tend to accept poorer outcomes, not knowing well enough what diagnostics or treatments to propose. MOSAICS has the ambitious goal to augment our understanding of the root causes and to propose effective diagnostics and explore personalised intervention in device fitting and rehabilitation, using a holistic and multidisciplinary approach.
Overall progress is in line with the Description of Action, even though the project was significantly impacted by the COVID-19 pandemic limiting access to research infrastructure and lab premises, causing delays in the planned clinical studies and reducing mobility. Nonetheless, the key players within the MOSAICS project, the four early-stage researchers (ESRs), were successfully recruited and started their research and training programme within MOSAICS in February 2020. Their research projects are organised around two work packages, WP1 “From cochlea to cortex” and WP2 “Brain, train and sustain”. Scientific progress in WP1 and WP2 is on track as creative solutions were found to mitigate delays caused by the COVID-19 pandemic, focusing on activities such as literature reviews and retrospective database analyses, as well as by preparing all the pre-clinical activities towards upcoming clinical studies, e.g. designing protocols and creating and validating the investigational devices.
In WP1, ESR1 and ESR4 study information bottlenecks in the bottom-up processes. ESR1 works on objective measures of how the auditory nerve and brain respond to electrical stimulation (diagnostics). He received ethical approval for a first clinical study and has collected initial data. He also drafted a technical report on his neural health literature findings. ESR4 focuses on the impact of the device fitting. He conducted a literature study and analysed a database of retrospective fitting and hearing outcome data. He is preparing for a prospective study. In WP2, ESR2 and ESR3 work on the central brain. ESR3 has commenced a pilot study in normal-hearing subjects, exploring the impact of working memory and inhibition on auditory perception. Her learnings will inform the study in CI subjects to be conducted during a secondment in early 2022. ESR3, working on outcome prediction and rehabilitation, has set up a prediction study where audiologists were presented with anonymized real case studies and asked to predict future hearing outcomes. Her data are currently being analysed. All ESRs have presented preliminary findings of their literature studies and pilot experiments at national and international conferences (contributing to the progress of WP4 dedicated to Outreach) and worked on papers and reports to be soon submitted for publication in peer-reviewed journals. They were also involved in communication activities aimed at raising awareness for MOSAICS and their research among a broad audience.
Moreover, during this reporting period, training (WP3) received a lot of focus as 12 out of 16 network-wide training modules specifically designed for MOSAICS were already offered and all four ESRs also engaged in individual training (e.g. ESR2 and ESR3 followed a MEG/EEG course), equipping them with foundational academic and non-academic skills towards their PhD and future career. They are all taking part in the PhD programme at the Donders Graduate School at Radboud University and successfully passed their first-year evaluation.
In WP1, ESR1 and ESR4 study information bottlenecks in the bottom-up processes. ESR1 works on objective measures of how the auditory nerve and brain respond to electrical stimulation (diagnostics). He received ethical approval for a first clinical study and has collected initial data. He also drafted a technical report on his neural health literature findings. ESR4 focuses on the impact of the device fitting. He conducted a literature study and analysed a database of retrospective fitting and hearing outcome data. He is preparing for a prospective study. In WP2, ESR2 and ESR3 work on the central brain. ESR3 has commenced a pilot study in normal-hearing subjects, exploring the impact of working memory and inhibition on auditory perception. Her learnings will inform the study in CI subjects to be conducted during a secondment in early 2022. ESR3, working on outcome prediction and rehabilitation, has set up a prediction study where audiologists were presented with anonymized real case studies and asked to predict future hearing outcomes. Her data are currently being analysed. All ESRs have presented preliminary findings of their literature studies and pilot experiments at national and international conferences (contributing to the progress of WP4 dedicated to Outreach) and worked on papers and reports to be soon submitted for publication in peer-reviewed journals. They were also involved in communication activities aimed at raising awareness for MOSAICS and their research among a broad audience.
Moreover, during this reporting period, training (WP3) received a lot of focus as 12 out of 16 network-wide training modules specifically designed for MOSAICS were already offered and all four ESRs also engaged in individual training (e.g. ESR2 and ESR3 followed a MEG/EEG course), equipping them with foundational academic and non-academic skills towards their PhD and future career. They are all taking part in the PhD programme at the Donders Graduate School at Radboud University and successfully passed their first-year evaluation.
Deafness has a profound impact on the quality of life of those suffering from it, disconnecting them from the people surrounding them. There is a global consensus on the fact that hearing loss is associated with depression, reduced cognition, and dementia. MOSAICS is contributing to the ultimate goal of making hearing implants globally accepted as the standard care solution for the ever-growing group of people affected by moderate-to-severe hearing loss and deafness. Multiple hurdles towards this objective exist at the patient and professional levels. MOSAICS’ holistic research program is helping the professional hearing community - counsellors, ENT surgeons, audiologists and therapists - by addressing knowledge gaps and piloting evidence-based diagnostics and treatments. The collective work of the four ESRs explores electrophysiological diagnostic approaches, device fitting, top-down processes and downstream effects of hearing outcomes on functioning and well-being.
Research outcomes will also help patients by empowering them with AI-powered tools for fitting and rehabilitation. As one of the project beneficiaries (Cochlear) is the leading manufacturer of hearing implants, promising concepts can be efficiently matured to become available as products for the global cochlear implant community. The project partners also include strong representations of the user community (European association of CI users) and the CI academic and clinical community, facilitating effective stakeholder dissemination.
Research outcomes will also help patients by empowering them with AI-powered tools for fitting and rehabilitation. As one of the project beneficiaries (Cochlear) is the leading manufacturer of hearing implants, promising concepts can be efficiently matured to become available as products for the global cochlear implant community. The project partners also include strong representations of the user community (European association of CI users) and the CI academic and clinical community, facilitating effective stakeholder dissemination.