Patients with some residual hearing Severe Hearing loss
Conditions
Interventions
The primary intervention of this study is a CI at severe hearing loss compared
to best fitted hearing aids. To achieve this comparison participants will be
randomly divided into two groups. Particip
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria are closely related to the clinical eligibiltiy criteria maintained at the medical center. In addition: 1.) Age between 18-65 years, the working population. 2.) Participants have severe post *lingual sensorineural hearing loss (as defined by WHO criteria of 61-81 dB loss). 3.) Eligible for CI based on clinical criteria and on the following audiometric data: - best aided phoneme score * 70% at 65/70dB HL - Communication need 4.) Sufficient understanding of the Dutch Language.
Exclusion criteria
Exclusion criteria: The following exclusion criteria are maintained for the study. 1.) Patient has an underlying syndrome. 2.) Pre-lingual Hearing impaired individuals. 3.) Sudden hearing loss. 4.) Children 0 * 18 years old. 5.) Elderly 65+ years old. 6.) Profound hearing loss 7.) Any condition that may hamper a complete insertion of the electrode array or a normal rehabilitation with the cochlear implant (severe otosclerosis or neurologic deficits)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation is the primary outcome of the study and is measured by using the Impact on Participation and Autonomy (IPA) questionnaire. The primary parameters are obtained by the domains family role; social life and relationships; and work and education. | — |
Secondary
| Measure | Time frame |
|---|---|
| Autonomy measured by IPA; domains: Autonomy outdoors, autonomy indoors. Communication profile Measured by the Amsterdam Questionnaire for Hearing Impairment and labour. The used domains are: Maladaptive behaviour, verbal strategies, non-verbal strategies, self-acceptance, acceptance of loss, stress and withdrawal. Work Measured by using the Amsterdam Questionnaire for Hearing Impairment and labour. The used domains are: Need for Recovery, participation, and relation to co-workers. Productivity loss measured by the Productivity Costs Questionnaire. Quality of life questionnaires (the generic HUI-3 and the disease specific NICQ) will be used in this study and are already part of standard clinical practice. Capabilities are measured by using the ICECAP-A questionnaire and by conducting semi-structured interviews. Cognition is measured by using the RBANS-H cognition test. Listening effort is measured by pupillometry. | — |
Countries
Netherlands
Outcome results
None listed