Method: The study is a multicentre, prospective, open, non-randomized, single-arm trial with sequential enrolment of all qualified patients, conducted under a common clinical investigation plan. Up to almost 2,000 evaluable patients have been enrolled from two Danish clinics. After having undergone medical and audiological examination and other assessments (health related and quality of life questionnaires), the patients were prescribed a hearing aid and got a fitting. Approximately 2 months later, a follow-up visit took place and whenever needed an adjustment was offered (plus other assessments). An across-center database, hosted independently from clinics, universities and hearing-aid manufacturers but accessible by all parties, was created to gather the data (access granted to each partner if data managers adhere to ethical permissions and requirements for data security).
Results: The investigation generated approximately 30’000 patient records and we started by characterizing the general distribution of audiometric data (air and bone conductions, speech tests) and questionnaires (health, speech, hearing aids, tinnitus and quality of life related). The analysis focused specifically on correlations detection between demographics, audiometric tests and questionnaires in order to classify patients into subsets.
Conclusion: The present clinical database should be seen as a starting point for other BEAR work packages. We believe that such large variety of data generated will lead to a more comprehensive picture of the hearing-aid user and will bring benefits to both clinicians and manufacturers. Indeed, this first step represents the baseline against which new fitting strategies will be tested. Alternatively, clinically relevant subpopulations with low hearing-aid benefit will be identified and studied to tentatively bring alternatives in rehabilitation.
|Publication date||22 May 2019|
|Publication status||Published - 22 May 2019|
|Event||Congress of the European Federation of Audiology Societies - Lisbon, Portugal|
Duration: 22 May 2019 → 25 May 2019
Conference number: 14
|Conference||Congress of the European Federation of Audiology Societies|
|Period||22/05/2019 → 25/05/2019|