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Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear (IROS)

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ClinicalTrials.gov Identifier: NCT02004353
Recruitment Status : Recruiting
First Posted : December 9, 2013
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief Summary:

The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.

Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.


Condition or disease Intervention/treatment
Hearing Loss Device: Cochlear® Hearing Implants

Detailed Description:

The clinical investigation is designed as a prospective repeated measures longitudinal study with intra-subject controls, using a selection of subjective evaluation tools to assess patient related benefits from hearing implant treatment of permanent hearing loss.

Clinically standard self-assessment scales, threshold measures and a general hearing history profile questionnaires for the clinician and implant recipient are made available for selection through an interface to a central electronic platform.

The registry is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear.

Patients are approached for registry participation following implant by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.

Monitoring of data entry is included through automated reminders via e-platform and through inherent audit trail.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Cochlear-Implanted Recipient Observational Study
Study Start Date : July 2011
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cochlear® Hearing Implants, hearing loss
Implanted Adolescents and Adults with permanent hearing loss
Device: Cochlear® Hearing Implants
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants




Primary Outcome Measures :
  1. Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [ Time Frame: Baseline (i.e. pre-implanted status) assessed prior to 1st switch-on ]
  2. Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [ Time Frame: post-implant at 1 year ]
  3. Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [ Time Frame: post-implant at 2 years ]
  4. Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [ Time Frame: Baseline (i.e. pre-implanted status) assessed prior to 1st switch-on ]
  5. Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [ Time Frame: post-implant at 1year ]
  6. Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [ Time Frame: post-implant at 2 years ]

Secondary Outcome Measures :
  1. Unaided hearing thresholds [ Time Frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz

  2. Unaided hearing thresholds [ Time Frame: immediately post-implant (optional) ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz

  3. Unaided hearing thresholds [ Time Frame: post-implant at 1 year ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz

  4. Unaided hearing thresholds [ Time Frame: post-implant at 2 years ]
    Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz


Other Outcome Measures:
  1. General Patient Hearing Profile Information [ Time Frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on ]
    General Patient Hearing Profile Information related to hearing history and daily hearing device use

  2. General Patient Hearing Profile Information [ Time Frame: post-implant at 1 year ]
    General Patient Hearing Profile Information related to hearing history and daily hearing device use

  3. General Patient Hearing Profile Information [ Time Frame: post-implant at 2 years ]
    General Patient Hearing Profile Information related to hearing history and daily hearing device use



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care routine clinical patients, with permanent hearing loss seeking implant treatment for hearing rehabilitation. Adolescent and Adult patients have limited or no benefit from conventional acoustic hearing aids.
Criteria

Inclusion Criteria:

  • Post-lingually deafened adults and adolescents who are newly implanted AND prior to first switch-on of their external device
  • Unilateral, bilateral simultaneous recipients of any implant device(s) available with market approval from the company Cochlear®
  • Children 10 years or older and in accordance with local regulations and product labelling
  • Mentally capable to respond to self-administered assessment scales
  • Willingness to participate and sign the Patient Informed Consent form

Exclusion Criteria:

  • Individuals excluded from participation in a registry according to national or local regulations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004353


Contacts
Contact: Herbert Mauch, Dipl.-Ing. +41795100092 hmauch@cochlear.com

  Show 72 Study Locations
Sponsors and Collaborators
Cochlear
Investigators
Study Director: Bart Volckaerts Cochlear

Publications:
Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02004353     History of Changes
Other Study ID Numbers: CEL 5277
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Keywords provided by Cochlear:
Cochlear® Hearing Implants

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms