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Completed

NCT Number: NCT02671032

CHANGE Feasibility Study

The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hearing Cooperative Research Centre, Carlton, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet current cochlear implant indications at the implanting centre
  • In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted.
  • Fluent speaker in the local language used to assess clinical performance
  • Eighteen years of age or older at the time of implantation with no upper age limit

Exclusion criteria

  • Evidence of hearing loss prior to 5 years of age.
  • Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
  • Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
  • Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
  • Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
  • Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
  • Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
  • Active middle-ear infection,
  • Tympanic membrane perforation
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
  • Unwillingness or inability of the candidate to comply with all investigational requirements.
  • Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
  • Patients with recurrent episodes of bacterial meningitis.

Treatment and study plan

Nucleus CI532 cochlear implant

Device

Primary outcomes

  1. Report on Degree of Hearing as Measured by Pure Tone Audiogram

    Time frame: 6 months and 12 months post activation

    unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.

  2. Report on Clinical Performance in Quiet and Noise

    Time frame: 3 months, 6 months and 12 months post activation

    Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).

  3. Report of Medical/Surgical and Device Related Adverse Events.

    Time frame: 12 months post activation.

    Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.

Secondary outcomes

  1. Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)

    Time frame: Preoperative and 6 months post activation

    Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.

  2. Glasgow Benefit Inventory (GBI).

    Time frame: 6 months post activation

    Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Royal Victoria Eye and Ear Hospital
  • The Hearing Cooperative Research Centre

Registry information

Official study title

Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.

Acronym: CLTD5626

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2016
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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