NL-OMON48029
Withdrawn
N/A
Societal merit of Intervention on hearing Loss Evaluation (SMILE) - SMILE
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 70
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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)
Outcomes
Primary Outcomes
Not specified
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