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Clinical Trials/NL-OMON44754
NL-OMON44754
Recruiting
Not Applicable

Cochlear Implantaton for siNGLE-sided seafness - CINGLE-trial

niversitair Medisch Centrum Utrecht0 sites120 target enrollmentTBD
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Conditionssingle sided deafnessunilateral sensorineural hearing loss10022396

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
single sided deafness
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
120
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •\- Age 18 or older.
  • •\- Acute onset of postlingual SSD, defined as onset unilateral hearing loss between \>\=3 months and \<\=10 years before time of inclusion.
  • •\- Hearing measurements:
  • •\> Pure Tone Audiometry of the deaf ear, defined as thresholds of 70 dB or higher on frequencies 0,5 \- 4\.0 kHz (average).
  • •\> Normal hearing on the contralateral ear, defined as pure tone audiometry thresholds of 30 dB or less on frequencies 0\.5 \- 4\.0 kHz (average).
  • •\> Air bone gap 10 dB or smaller.
  • •\- Normal function of middle ear (i.e. no acute middle ear infections or tympanic membrane perforations).
  • •\- Dutch language proficiency.
  • •\- Willingness and ability to participate in all scheduled procedures outlined in the protocol.
  • •\- General health allowing general anaesthesia for the potential surgical implantation of a CI or BAHA.

Exclusion Criteria

  • •\- previous experience with implanted BAHA or CI
  • •\- retrocochlear pathology
  • •\- abnormal cochlear anatomy in one or both ears (i.e. ossification)
  • •\- disability which could interfere with the completion of the tests (i.e. psychiatric problems or severe comorbidity with an expected survival of less than five years)

Outcomes

Primary Outcomes

Not specified

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