H90.3 H90.4
Conditions
Interventions
Group 1: Newly fitted with a CI (branch 1)
This study arm is randomised and controlled. After information and consent, you will receive a specialist and audiological rehabilitation plan and examinati
Sponsors
Cochlear Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: • Age of 18 years or older • CI from the company Cochlear (speech processor CP1000, CP1110 or Kanso2 (CP1150)) • Newly fitted CI patients or patients just before implantation • Average cognitive abilities (regular school-leaving qualification) • Signed informed consent form • Sufficient German language skills
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Age < 18 years • Neurological or psychiatric diseases • Non-consenting patients • Insufficient German language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to prove that both groups are objectively and subjectively supported comparably well, but that the additional use of the apps achieves economic and time savings compared to purely clinical audiological follow-up examinations and that increased satisfaction with care can be achieved among CI users. This efficiency assessment is evaluated in a clinical context. It is operationalised by the following target variables in a group comparison (randomised controlled trial): Reduction of fitting and care time in the clinical-audiological setting (time in minutes); efficiency evaluation in the clinical context; RCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Identify and describe a participant/patient group that is comfortable with using the apps in the daily routine. The following variables will be collected: • Frequency of use of the apps (evaluated via app usage data in the myCochlear Professional portal database) related to age, gender, time of deafness, time of CI fitting, time of fitting with CP1000, CP1110 or Kanso2 (CP1150) speech processor, education, occupation, self-assessed affinity for technology and individual technical equipment (the latter collected by means of a questionnaire at study inclusion) • Reasons for or against using the apps in the course of the study (compliance questionnaire with response options at time T2) • Recommendation to include the apps in the current CI guideline (AWMF) • The "HEAR-COMMAND Tool" is used at different points in the course of the study (prospective cohort sub-study) for rehabilitation aspects, esp. newly fitted participants. Additionally cross-sectional data from the post fitting group to compare with the HEAR-COMMAND results with hearing aid users. • Satisfaction with care according to HearDL and questionnaires (including EMA) • Success of care according to the adaptive Digit Triplet Test (DTT) and the Oldenburg Sentence Test (OLSA) in background noise as follow-up parameters. Combination of HEAR-COMMAND Tool and HearDL with EMA enables statements on better use in the everyday life of CI participants. | — |
Countries
Germany
Contacts
Public ContactPhilipp Mathmann
Klinik für Phoniatrie und Pädaudiologie, Universitätsklinikum Münster
Outcome results
None listed