Implantation of the HiRes90K Advantage Cochlear Implant With HiFocus Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

  • STATUS
    Recruiting
  • days left to enroll
    72
  • participants needed
    50
  • sponsor
    Advanced Bionics
Updated on 22 January 2021
cochlear implant
sensorineural hearing loss
hard of hearing
audiogram
auditory stimulation

Summary

The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution 90K Advantage cochlear implant with the HiFocus Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

Details
Condition Deafness, EAR DISORDER, Otorhinolaryngologic Diseases, Hearing Loss, Dysacusis, Auditory Loss and Deafness, Partial Deafness, Hearing Impairment, hearing disorders, decreased hearing, hard of hearing, hypoacusis, ear disorders, ear diseases
Treatment HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, EAS sound processor
Clinical Study IdentifierNCT02189798
SponsorAdvanced Bionics
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Partial Deafness or Hearing Loss or Otorhinolaryngologic Diseases or EAR DISORDER or Dysacusis?
Do you have any of these conditions: hearing disorders or Deafness or ear diseases or Hearing Loss or Partial Deafness or Dysacusis or Auditory Loss and Deafness or decreased hearing or e...?
Newly Implanted and Existing Implanted Groups
Ability to provide informed consent
years of age or older, unilaterally implanted with HiRes90K Advantage cochlear implant with HiFocus Mid-Scala electrode and fit with an ear-level sound processor (i.e. Nada family device)
Postoperative unaided low frequency audiometric hearing thresholds in the treated ear up to 80 dB HL for at least one frequency from 125 - 1000 Hz
English Language Proficiency
Willingness to participate in all scheduled procedures outlined in the study protocol

Exclusion Criteria

Newly Implanted and Existing Implanted Groups
Unilaterally implanted with HiRes 90K Advantage cochlear implant with HiFocus Helix and HiFocus 1j electrode
Exclusive use of a body worn external sound processor
Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
Postoperative unaided low frequency audiometric hearing thresholds in the treated ear exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
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