Patients with severe or extremely severe sensorineural deafness in both ears
Conditions
Interventions
Experimental group:CS-30A (TM) cochlear implant
Sponsors
Hangzhou Normal University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) 18 to 65 years old; 2) Severe or extremely severe sensorineural hearing loss in both ears; 3) The hearing aid is ineffective or ineffective, with an open short sentence recognition rate of = 50% under binaural hearing conditions (70dBSPL); 4)The main way of daily communication is through auditory language; 5)No surgical contraindications; 6)Agree to participate in the experiment and sign the informed consent form. Audiology and imaging assessment must simultaneously meet the following conditions AAudiological assessment (within the past month) ?Objective Audiological Examination: a)Acoustic reflection without response; b) Otoacoustic emission DPoAE not elicited on both sides. ?Subjective audiological examination: a)Auditory threshold measurement: bare ear 0.5, 1, 2, 4 kHz mean = 85 dBHL; b) Hearing aid threshold of 2 kHz and above does not enter the banana chart; c) Short sentence recognition in Chinese auditory assessment test = 30%, all closed listening Ability to evaluate testing (environmental sound detection: initial consonant recognition, vowel recognition, tone)The average recognition rate of recognition, word recognition, two character recognition, and number recognition=50 %. BImaging assessment (within the past 6 months) High resolution thin-layer CT of temporal bone: Interval between layers = 2 mm, window width 3000-4000, window level 500-700. The structure of the inner ear and internal auditory canal is normal, and there are no serious diseases of the middle ear, mastoid process, or Eustachian tube (horizontal or coronal).
Exclusion criteria
Exclusion criteria: 1) Allergic to the material of the implant; 2) Severe inner ear malformation; 3)Deafness is caused by non cochlear lesions; 4) Individuals with middle ear infection or unhealed tympanic membrane perforation; 5) Patients with other serious diseases, such as diabetes, heart disease, etc; 6) Individuals with abnormal brain structures, such as abnormal white matter development, demyelinating diseases, etc; 7)Patients with epilepsy, intellectual disabilities, mental illnesses, scars, and susceptible constitution; 8) Unable to cooperate with audiology assessments and language trainers; 9) The general condition of the body is poor and the patient cannot undergo surgery; 10) Metal or magnetic objects inside or on the body surface, such as electronic/metal implants or prostheses, transdermal drug delivery patches with metal backing, etc; 11) Contraindications for MRI examination; 12) Breastfeeding, pregnant women, and those with recent fertility plans; 13) Unsuitable participants evaluated by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of cochlear implant displacement after MRI magnetic resonance detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in pure tone hearing threshold;Changes in speech recognition rate;Changes in eABR induced auditory brainstem response by electrical stimulation;Overall performance evaluation of implants;Changes in laboratory examination before/after implantation;Artifact size after MRI detection;Adverse event questionnaire score after MRI examination;Incidence of device defect; | — |
Countries
China
Contacts
Public ContactLi Yuan
Hangzhou Normal University Affiliated Hospital
Outcome results
None listed