Community Research and Development Information Service - CORDIS

Periodic Reporting for period 1 - Fox-IT (Fitting-to-Outcome eXpert for semi-automated cochlear implant fine-tuning)

Reporting period: 2016-08-01 to 2016-11-30

Summary of the context and overall objectives of the project

For many deaf patients cochlear implantation has become the standard state-of-the-art care. To achieve optimal hearing performance, cochlear implants need to be adjusted to the individual needs of the user. To date, this has to be done manually by an experienced audiologist. It involves a complex procedure requiring many hours of work in multiple sessions.
Our business innovation consists in creating a new semi-automated fine-tuning method by using powerful methods from artificial intelligence. To do so, the implant behavior in response to speech sounds was first modeled mathematically, and subsequently, artificial intelligence algorithms and networks were written and validated. Our new fine-tuning method is groundbreaking in that provides systematics, eradicates unjustifiable variation, reaches preset targets and requires only minimal intervention from an audiologist.

Being clinically validated, the prototype of the FOX Fitting-to-Outcome eXpert is ready for demonstration in cochlear implant centers worldwide. It is also a first and crucial step in the introduction of eHealth in the field of audiology, empowering patients to take up an active role in the frequency and the way in which their implant is adjusted. For developing countries, it paves the way to bringing modern hearing rehabilitation to otherwise underserved areas.
The main objective of the Phase 1 project was to assess the technological and market-economic viability of FOX as well as its acceptance by the targeted purchasers and end-users. The feasibility analysis was performed together with Flanders Inshape, a competence center of the Antwerp University Management School. The outcomes of the project showed that FOX is a highly qualitative automated fitting technique that is capable of providing a cost-effective solution for hearing health care to a steadily increasing population of cochlear implant users worldwide.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In agreement with the project proposal, the feasibility study consisted of two stages: the first one aimed to make a value proposition for our business innovation idea; the second one targeted the development of several potential business models.
The first stage of our feasibility analysis consisted in assessing the technological and economic viability of the FOX® prototype in terms of the business opportunities presented by the steadily growing market of cochlear implantation. An important outcome of consisted in the identification of the market needs and the unique values offered by FOX® within the market of individualized and highly specialized hearing care. This resulted in a Value Proposition, visualized as one of the segments of a business canvas model. The outcomes of the analysis showed that the main advantage of this clinical product is that it will require little to no intervention by human expert-audiologists while it is nevertheless able to guarantee that hearing outcomes are within the highest standards. In-depth interviews with expert CI-fitters and potential new users of FOX® within specialized audiological centres revealed that they highly appreciate the fact that this new fitting software will reduce unwanted variability amongst individual expert fitters and amongst fitting centres world-wide. Also, they feel that FOX® will create confidence amongst CI-fitters with respect to the obtained hearing outcomes. As fitting towards measurable targets is one of the core principles behind the proposed automated fitting method, it is also expected to play a key role in patient satisfaction.
Importantly, the interviews also enabled us to identify potential pitfalls towards the successful introduction of FOX® into the market. These pains include e.g. the expected loss of prestige or ‘ego-pain’ of which expert audiologists and CI fitting centres may suffer when discovering that the computer is able to do an important part of the fitting task faster and with better hearing outcomes than when it is done manually. Also, (potential) users expressed the fear to be confronted with interface problems, bugs, errors of all kinds that they are no longer able to handle on their own due to the high technological level of the product.
During stage 2 of the feasibility study several business models were developed, based on in-depth interviews with representatives from potential customers. As a starting point, two potential business 'routes' were identified: a direct one, consisting in selling the product to CI centres and their end-users (audiologists) directly, and an indirect one in which the sales channel would pass through the CI manufacturers.
The different business workshops held with CI end users and two of the market leading CI manufacturers (Cochlear, Advanced Bionics) revealed that the existing FOX prototype is an interesting solution for end-users represented by experienced fitting audiologists who are typically working in audiological centres specialized in cochlear implantation hearing services.
The outcomes of the business model development sessions indicate that for FOX®, new marketing activities ideally consist of co-marketing with one or more cochlear implant companies, who may consider the new fitting software as a competitive advantage in a challenged market. Reaching the market through CI manufacturers has a number of important advantages over a direct marketing strategy that would target the ca. 2000 CI centres directly. Firstly, recurrent revenues can be expressed in terms of the number of cochlear implant speech processors that need to be fine-tuned world-wide each year. The fine-tuning of cochlear implants does not only involve the switch-on and follow-up procedures of new implantees, but also the yearly check-up and the optimization of the cochlear implant settings to the changes in the individual patient profiles. Secondly, by targeting the market segment of CI manufacturers, Otoconsult NV can concentrate on familiar competences such as innovation, R&D, (Train-the-Trainer) training of audiologists/CI fitters, and providing helpdesk support. Activities in which the company has less in-house experience (regulatory affairs, marketing, sales) could be taken care of by its key partners, i.e. the CI manufacturers.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Worldwide, it is anticipated that there will be an important increase in the demand for cochlear implants, not only due to the prevalence of deafness in the steadily increasing number of elderly individuals in Western societies, but also because of the fact that the results of hearing performance with cochlear implants are so good that the criteria for implantation are slowly being loosened, opening the way to the implantation of patients with single-sided deafness, partial deafness, and severe hearing loss (in contrast to profound hearing loss or deafness).
In a recently published report The Ear Foundation provides a set of recommendations in order to address Europe’s growing challenge of hearing loss in adults. These include, amongst others a more cost-effective approach to providing hearing technology to those who need it, a revision of the candidacy requirement for cochlear implantation (to include also a subpopulation of hearing impaired individuals who are currently using classical behind-the-ear hearing aids), the development of innovative service models that can be used in tele-therapy, and the training of professionals who are involved in providing audiological services to cochlear implant users.
The outcomes of the feasibility study show that if Otoconsult NV is able to transform the existing FOX® prototype into a product that is ready to enter the market, it will be able to address these specific recommendations and extend its business activities in the global niche-market of cochlear implantation, delivering highly qualitative and efficient care to the steadily increasing number of individuals with a hearing impairment in the EU. But the impact of the proposed innovation does not stop at the EU borders. Global connectivity being steadily growing, FOX® clearly offers a promising opportunity to provide cost-effective hearing health care to patients which may otherwise be deprived from it due to geographical and economic barriers as is the case in many third world countries.

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