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Clinical Trials/NL-OMON48029
NL-OMON48029
Withdrawn
N/A

Societal merit of Intervention on hearing Loss Evaluation (SMILE) - SMILE

Radboud Universitair Medisch Centrum0 sites70 target enrollmentTBD

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Withdrawn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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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