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Bimodal, CROS and Severe Profound Hearing Loss Study

Primary Purpose

Cochlear Implant, Severe-Profound Hearing Loss, Hearing Loss, Bilateral

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fitting strategy of cohlear implant of hearing aid
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cochlear Implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Consistent unilateral user of an Advanced Bionics cochlear implant and a contralateral hearing aid for at least 6 months, ideally 12 months, and Bilateral severe to profound hearing loss (meeting NICE criteria for implantation-2009). (group 1)
  • Consistent unilateral user of an Advanced Bionics cochlear implant for at least 6 months and ideally 12 months, with no useful contralateral hearing (group 2)
  • Consistent user of bilateral hearing aids for at least six months (group 3) and bilateral severe profound hearing loss (80dB or worse at 2000 and 4000 Hz with speech discrimination of at least 50% IHR sentences live voice at 60dBA)
  • First language English
  • Post-lingual onset of severe to profound hearing loss
  • No other handicaps that would interfere with participation in the study in the opinion of the Principle Investigator

Exclusion Criteria:

  • Unstable cochlear implant or hearing aid fitting
  • Using medication in an intermittent manner that might influence hearing levels
  • Cognitive or psychological challenges that might lead to variations in attention

Sites / Locations

  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Cochlear Implant and Hearing Aid

Cochlear Implant alone

Hearing Aid and Hearing Aid

Arm Description

Comparing performance of conventional hearing aid fitting to Phonak's Bimodal Fitting formula using the Phonak Naida Link hearing aid. All patients are tested in a bimodal (hearing aid plus cochlear implant) setup. Initial tests are completed with the Advanced Bionics Naida Q70 or Q90 sound processor and the patient's own hearing aid. In this arm, a patient's own hearing aid is replaced with the Phonak Naida Link hearing aid to test if there is a benefit.

To determine if the addition of a contralateral routing of signal (CROS) microphone on the un-implanted ear improves performance. Baseline tests are completed with Advanced Bionics Naida Q70 or Q90 sound processors. Patients are then given the Phonak Naida Link CROS aid to test if there is a benefit.

Comparing performance of conventional hearing aid fitting to a modified signal processing strategy more aligned with how a cochlear implant manages sound. All patients are tested initially with their own hearing aids to obtain a baseline measurement. Patients are then fitted with a modified Phonak hearing aid to determine if performance improves.

Outcomes

Primary Outcome Measures

Sound Processing parameters
ASSE score

Secondary Outcome Measures

Full Information

First Posted
January 23, 2019
Last Updated
June 30, 2021
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
Advanced Bionics AG
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1. Study Identification

Unique Protocol Identification Number
NCT04222296
Brief Title
Bimodal, CROS and Severe Profound Hearing Loss Study
Official Title
Clinical Evaluation of Outcomes With Hearing Aid Parameters Designed for Adults With Severe-profound Hearing Loss and Unilateral Cochlear Implants in Bimodal (Cochlear Implant and Contralateral Hearing Instrument), CROS (Contralateral Routing of Signals) and Bilateral Amplification Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
Advanced Bionics AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids. This will enable a comparison of standard fitting protocols against the new rationale using the same devices. Devices used for patients in all 3 groups are now available in standard of care, and can be kept afterwards should the patients wish.
Detailed Description
The study will involve three groups of 20 patients per group. This first is experienced adult bimodal users of the AB system who have usable contralateral residual hearing. A clinical baseline and three research conditions will be evaluated. The Naida CI Link HA (Link) will be fitted, tested and then optimised using a special bimodal fitting formula. Subjects will be allowed three months to acclimatize and will then be retested. The second research condition will evaluate the fully integrated bimodal system, where the microphone signals from CI and HA are shared and a bilateral beamformer is formed. A third intervention will involve modifying the CI settings to minimize the mis-match between frequencies delivered via the CI. A second group with no aidable hearing on their non-implanted ear will also be studied. A contralateral routing of signal (CROS) device will send sounds on the non-implanted side. Tests will be made with and without CROS, as well as with directional microphone settings. Finally as a control group, bilateral HA users will be tested with the similar HA fitting as used for the bimodal group. This will enable a comparison of standard fitting protocols against the new rationale using the same devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Implant, Severe-Profound Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Cochlear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochlear Implant and Hearing Aid
Arm Type
Other
Arm Description
Comparing performance of conventional hearing aid fitting to Phonak's Bimodal Fitting formula using the Phonak Naida Link hearing aid. All patients are tested in a bimodal (hearing aid plus cochlear implant) setup. Initial tests are completed with the Advanced Bionics Naida Q70 or Q90 sound processor and the patient's own hearing aid. In this arm, a patient's own hearing aid is replaced with the Phonak Naida Link hearing aid to test if there is a benefit.
Arm Title
Cochlear Implant alone
Arm Type
Other
Arm Description
To determine if the addition of a contralateral routing of signal (CROS) microphone on the un-implanted ear improves performance. Baseline tests are completed with Advanced Bionics Naida Q70 or Q90 sound processors. Patients are then given the Phonak Naida Link CROS aid to test if there is a benefit.
Arm Title
Hearing Aid and Hearing Aid
Arm Type
Other
Arm Description
Comparing performance of conventional hearing aid fitting to a modified signal processing strategy more aligned with how a cochlear implant manages sound. All patients are tested initially with their own hearing aids to obtain a baseline measurement. Patients are then fitted with a modified Phonak hearing aid to determine if performance improves.
Intervention Type
Device
Intervention Name(s)
Fitting strategy of cohlear implant of hearing aid
Intervention Description
To determine whether new hardware and fitting strategy provides better sound quality or ease of use than generic hardware and fitting methods
Primary Outcome Measure Information:
Title
Sound Processing parameters
Description
ASSE score
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Consistent unilateral user of an Advanced Bionics cochlear implant and a contralateral hearing aid for at least 6 months, ideally 12 months, and Bilateral severe to profound hearing loss (meeting NICE criteria for implantation-2009). (group 1) Consistent unilateral user of an Advanced Bionics cochlear implant for at least 6 months and ideally 12 months, with no useful contralateral hearing (group 2) Consistent user of bilateral hearing aids for at least six months (group 3) and bilateral severe profound hearing loss (80dB or worse at 2000 and 4000 Hz with speech discrimination of at least 50% IHR sentences live voice at 60dBA) First language English Post-lingual onset of severe to profound hearing loss No other handicaps that would interfere with participation in the study in the opinion of the Principle Investigator Exclusion Criteria: Unstable cochlear implant or hearing aid fitting Using medication in an intermittent manner that might influence hearing levels Cognitive or psychological challenges that might lead to variations in attention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Tysome
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 OQQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bimodal, CROS and Severe Profound Hearing Loss Study

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