Societal merit of Intervention on hearing Loss Evaluation (SMILE)

Withdrawn

Conditions: Patients with some residual hearing
Severe Hearing loss
10019243

Registration Number: NL-OMON48029

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 70

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Participation is the primary outcome of the study and is measured by using the<br /><br>Impact on Participation and Autonomy (IPA) questionnaire. The primary<br /><br>parameters are obtained by the domains family role; social life and<br /><br>relationships; and work and education. </p><br>

Secondary Outcome Measures