NCT04222296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

January 23, 2019

Last Update Submit

June 30, 2021

Conditions

Cochlear ImplantSevere-Profound Hearing LossHearing Loss, BilateralHearing Loss, Cochlear

Outcome Measures

Primary Outcomes (1)

  • Sound Processing parameters

    ASSE score

    24 months

Study Arms (3)

Cochlear Implant and Hearing Aid

OTHER

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.

Device: Fitting strategy of cohlear implant of hearing aid

Cochlear Implant alone

OTHER

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.

Device: Fitting strategy of cohlear implant of hearing aid

Hearing Aid and Hearing Aid

OTHER

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.

Device: Fitting strategy of cohlear implant of hearing aid

Interventions

Fitting strategy of cohlear implant of hearing aidDEVICE

To determine whether new hardware and fitting strategy provides better sound quality or ease of use than generic hardware and fitting methods

Cochlear Implant aloneCochlear Implant and Hearing AidHearing Aid and Hearing Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, CB2 OQQ, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, BilateralHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James R Tysome

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant ENT and Skull Base Surgeon

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 9, 2020

Study Start

September 4, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

July 2, 2021

Record last verified: 2021-06

Locations

GB(1)