CIDEX

JRCT ID: jRCTs032230528

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Residual hearing in low frequencies and severe to profound sensorineural hearing loss in high freque
• Date of first enrollment: 21/12/2023
• Target sample size: 1
• Study type: Interventional
• Intervention(s): The cochlear implantation is performed under general anesthesia. Same as standard cochlea implant surgeries for bilateral healing loss, an antromastoidectomy is performed, followed by an atticotomy and posterior tympanotomy and insert cochlear implant electrode to cochlea and fix implanted electrode and signal receiver. The implant system can be activated, after the swelling of the skin flap above the implant has reduced.

Outcome(s)

Primary Outcome

Clinical performance of the Mi1250 SYNCHRONY 2 FLEX28 DEX: change in mean/median speech perception outcome as % correct of speech test in quiet (Japanese Monosyllable test: iCI2004) from prior to implantation to 7 months post-implantation with the Mi1250 SYNCHRONY 2 FLEX28 DEX.
*iCI2004 test: Nishio et al., Acta Otolaryngol. 2021;141(3):267-272.

• Secondary Outcome: For the study to be considered a success, results of the benefit-risk assessment shall be positive.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

General criteria
(1)Patient agreed to participate in the study and signed to the informed consent document.
(2)Age of 18 years or older when agreed.
(3)General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon.

Medical criteria
(1)Post-lingual hearing loss.
(2)The pure tone average of affected side was below:
Equal to 85dB HL or below at 125Hz
Equal to 90dB HL or below at 250Hz
Equal to 60dB HL or over at 2000Hz - 8000Hz
(3)Evidence of functional auditory nerve in the ear to be implanted.
(4)Subject report of having used an optimally fit hearing aids for a minimum of three months before deciding that a cochlear implant is the preferential option.
(5)Cochlear anatomy compatible with the insertion of a FLEX28 electrode array.

Exclude criteria

(1)Evidence of ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or might cause an increased risk of infection (e.g., dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT (Computed Tomography/Magnetic Resonance Tomography).
(2)Evidence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull.
(3)Known allergic reaction or intolerance to the materials used in the implant.
(4)Known absence of cochlear development or if the cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway.
(5)Evidence of active external or middle ear infection or history of recurrent middle ear infection in the ear to be implanted.
(6)Evidence of perforated tympanic membrane in the ear to be implanted.
(7)Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks before enrolment.
(8)Evidence of concomitant use of medicinal substances that could alter the therapeutic efficacy of dexamethasone.
(9)Unwillingness or inability of the candidate to comply with all investigational requirements.
(10)Evidence of medical contraindications to surgery of the middle and inner ear and anaesthesia.
(11)Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation.

Related Information

• Primary Sponsor: Usami Shin-ichi
• Source(s) of Monetary Support: MED-EL Japan Co. Ltd.,MED-EL Electro-Medizinische Gerate GmbHMedel GMBH