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Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System

NCT02722330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-06-03

Study results available
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Summary

The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.

Conditions

  • Single Sided Sensorineural Deafness
  • Mixed Hearing Loss, Unilateral

Interventions

DEVICE

Baha 5 SuperPower on Baha Attract System

The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.

Sponsors & Collaborators

  • Cochlear Bone Anchored Solutions

    lead INDUSTRY

Principal Investigators

  • Jaydip Ray, Professor · Royal Hallamshire Hospital

  • César Orús, Dr · Hospital de Sant Pau

  • Paul Van de Heyning, Professor · University Hospital, Antwerp

  • Jesper Schmidt, Dr · Odense University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Belgium
  • Denmark
  • Spain
  • 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 NCT02722330 on ClinicalTrials.gov