In December 2020, the French Medical Device and Health Technology Evaluation Committee
(CNEDiMTS) voted in favour of the integration of telemonitoring in cochlear implant
users' follow-up thus adding a range of new possibilities to a standard health care
routine.
According to the official recommendations of the French National Authority for Health, a
patient implanted for a sufficiently long time should be seen annually at the
implantation reference center. This periodicity might appear too low, in which case a
patient will have to organise an unscheduled check-up appointment. Such appointments are
a source of various problems: firstly, they disorganise the routine of the reference
centers not adapted for emergency and semi-emergency situations; secondly, the patient
might encounter substantial travelling fees (only 22 refence centers in France),
especially if an implant component to replace is out of stock. Having an utility of
remote patient monitoring is also beneficial in situations where the access to health
care system is restricted, for example, the recent pandemic of Covid 19.
Cochlear™ has recently designed an at-home based patient testing tool, Remote Check
application, permitting to complete a series of hearing test from a compatible
smartphone. The results are then sent to the implantation reference center and evaluated
by healthcare professionals. The data is securely stored on Cloud accessible to
authorised clinicians via MyCochlear site.
Although the feasibility and the accuracy in detecting technical problems of remote
follow-up of people with cochlear implant had been already assessed, its impact on health
care system is still unknown. Hence, this project will be the first to evaluate an
interest of implementing remote monitoring in following adults with cochlear
implantation.
The main objective of the study is - to determine if the use of telemonitoring through
Remote Check application reduces significantly a number of unscheduled check-up
appointments in the reference centre during 1 year follow-up period for a patient with a
cochlear implant Cochlear™ in comparison to traditional health care approach.
The secondary objectives are:
To compare a number of scheduled appointments during a period of Remote Check use
versus a historical period of a traditional follow-up
To compare a number of indispensable unscheduled visits (unavoidable with or without
Remote Check use) with a number of unnecessary ones (avoidable with Remote Check)
To measure the compliance of the Remote Check application use
To assess quantitatively and qualitatively a number of implant failures/dysfunctions
identified with Remote Check
To evaluate for each study participant time spent by clinician to treat Remote Check
analysis data uploaded to My Cochlear data base
To assess patients satisfaction of Remote Check implementation in their healthcare
routine
To evaluate the quality of life specific to the Deaf before and after Remote Check
use The study implies four visits for each patient. The inclusion visit (V0) is a
routine check-up appointment in the implantation reference center. After the patient
is informed and his/her consent is collected, the Remote Check application will be
activated on his/her processor. Two next follow-up visits, V1 (V0+ 5 mois (± 0.5
mois)) and V2 (V0 + 11 mois (± 0.5 mois)), are remote visits with hearing test
performed through Remote Check application. Final visit, V3 (V0 + 12 mois (± 0.5
mois)), corresponds to patient's annual check-up appointment. In case a problem with
processor's functioning is detected during V2, it will be resolved at V3. Equipment
verification will be also performed to detect failures missed by Remote Check.