Phase
Condition
Hearing Loss
Deafness
Hearing Impairment
Treatment
Categorical loudness scaling based fitting using the Nexus Research System.
Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18 years or older (no upper age limit).
Post-lingually deafened defined as severe or greater sensorineural hearing lossonset after the age of 2 years as reported by the subject
Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
Fluent speaker in the language used to assess speech perception performance, asdetermined by the investigator.
Willingness to participate in and comply with all requirements of the protocol.
Willing and able to provide written informed consent
Exclusion
Exclusion Criteria:
Score below 3 on the screening subset of questions from the Mobile DeviceProficiency Questionnaire.
Subject who will be programmed with an acoustic component in the implanted ear.
Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less thanor equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
Diagnosis of auditory neuropathy.
Additional health factors, known to the investigator, that would prevent or restrictparticipation in the evaluations, including significant visual impairment and/ordexterity issues.
Unable or unwilling to comply with the requirements of the clinical investigation asdetermined by the Investigator.
Investigator site personnel directly affiliated with this study and/or theirimmediate families: immediate family is defined as a spouse, parent, child, orsibling.
Cochlear employees or employees of Contract Research Organizations or contractorsengaged by Cochlear for the purposes of this investigation.
Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device (unlessthe other investigation was/is a Cochlear sponsored investigation and determined bythe investigator or Sponsor to not impact this investigation). -
Study Design
Study Description
Connect with a study center
HEARnet
Carlton, Victoria 3053
AustraliaSite Not Available
Cochlear Sydney
Sydney, 2113
AustraliaSite Not Available
Medizinische Hochschuke Hannover (MHH)
Hannover, 30625
GermanySite Not Available
Medizinische Hochschule Hannover (MHH)
Hannover, 30625
GermanySite Not Available
Cochlear Americas
Lone Tree, Colorado 80124
United StatesSite Not Available
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