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Bimodal, CROS and Severe Profound Hearing Loss Study

NCT04222296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-07-02

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Fitting strategy of cohlear implant of hearing aid

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

Sponsors & Collaborators

  • Advanced Bionics AG

    collaborator INDUSTRY

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • James R Tysome · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04222296 on ClinicalTrials.gov