CompletedNot Applicable

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

Belgium, Denmark, Spain23 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult subjects ≥ 18 years of age * Mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4, Mean of 0.5, 1, 2 and 4kHz) of 30-55 dBHL or * Single-sided sensorineural deafness: Bone conduction thresholds with a pure tone average \[PTA4, Mean of 0.5, 1, 2 and 4 kHz\] of lower or 30 dBHL in the best ear. Subjects who have, for some reason, experienced no or limited benefit from other sound processors when tested on a Baha Softband. * Subjects suitable for surgery according to the recommended surgical procedure for Cochlear Baha 5 SuperPower with no previous implant on the side to be investigated. * Signed inform consent. Exclusion Criteria: * Subject scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Investigational device (however, bilateral hearing loss is not an exclusion criterion). * Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness * Less than 3 mm soft tissue thickness at the planned implant site. (Intra-operative exclusion criteria judged by the surgeon at Visit 1 or Visit 2 according to local practice). * Subjects that have received radiation therapy at the same side of the skull where the Investigational device will be positioned. * Uncontrolled diabetes as judged by the investigator. * Condition that could jeopardise osseointegration an…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided

Timeframe: 12 weeks

Trial details

NCT IDNCT02722330

SponsorCochlear Bone Anchored Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2018-02-01

View on ClinicalTrials.gov More Single Sided Sensorineural Deafness trials