Cochlear Implantaton for siNGLE-sided seafness - CINGLE-trial

niversitair Medisch Centrum Utrecht0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- 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.
•- Patients covered by the Dutch health insurance.
•- Patients should agree to be implanted with a CI or BAHA.
•- Informed consent understood, filled out and signed by patient.
•- Patients are not allowed to participate in another ongoing research study related to SSD or cochlear implantation

•- 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)

发起方

niversitair Medisch Centrum Utrecht