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Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear

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ClinicalTrials.gov Identifier: NCT03867396
Recruitment Status : Enrolling by invitation
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.

This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.


Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Device: CROS Device: Hearing Aid Other: Cochlear Implant Alone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients Using Either a Conventional Hearing Aid or a CROS Device on the Contralateral Ear
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cochlear Implant and Hearing Aid
Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.
Device: Hearing Aid
Advanced Bionics Naida hearing aid

Active Comparator: Cochlear Implant alone
Subject only uses the cochlear implant; hearing on the contralateral side is unaided.
Other: Cochlear Implant Alone
No hearing device on contralateral ear

Experimental: Cochlear Implant and CROS
Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.
Device: CROS
Advanced Bionics CROS




Primary Outcome Measures :
  1. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  2. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  3. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from in front of the person (Front) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  4. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #4 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  5. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #5 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  6. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #6 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  7. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #7 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  8. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #8 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  9. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #9 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  10. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #10 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  11. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #11 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  12. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #12 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  13. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #13 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  14. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #14 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  15. Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #15 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.


Secondary Outcome Measures :
  1. Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #16 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  2. Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #17 will ask the subject how difficult it was to listen to speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  3. Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #18 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  4. Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #19 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  5. Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #20 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  6. Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #21 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  7. Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #22 will ask the subject how difficult it was to listen to speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  8. Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #23 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  9. Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #24 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  10. Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #25 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  11. Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #26 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  12. Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #27 will ask the subject how difficult it was to listen to speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  13. Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #28 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  14. Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #29 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  15. Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #30 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  16. Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #31 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  17. Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #32 will assess speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  18. Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #33 will assess speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  19. Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #34 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  20. Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #35 will assess speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  21. Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #36 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  22. Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #37 will assess speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  23. Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #38 will assess speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  24. Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #39 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  25. Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #40 will assess speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  26. Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #41 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  27. Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #42 will assess speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  28. Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #43 will assess speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  29. Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #44 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  30. Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #45 will assess speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria*:

  • An Advanced Bionics cochlear implant recipient with at least 12 months of listening experience
  • Low frequency PTA

Exclusion Criteria*:

  • Non-English speakers

    • Additional Inclusion and Exclusion criteria apply

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): NCT03867396


Locations
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United States, Colorado
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Melinda Anderson, PhD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03867396     History of Changes
Other Study ID Numbers: 18-1101
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with Advanced Bionics.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: From first patient through IRB study close.
Access Criteria: The de-identified data will be shared to with Advanced Biionics in a password protected Excel sheet downloaded from research database.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Colorado, Denver:
Cochlear Implant
Hearing Loss
Hearing Aids
Hearing Tests

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