Completed

Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up

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What is being tested

Baha Attract System

Device
Who is being recruted

Ear Diseases+8

+ Hearing Disorders

+ Nervous System Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorCochlear Bone Anchored Solutions
Last updated: February 6, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery: To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband Which sound processor to select, i.e. BP100 vs BP110 Improve the fitting process for the sound processor Selection of sound processor magnet at time of fitting and over time

NCT01822119
Principal SponsorCochlear Bone Anchored Solutions
Last updated: February 6, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesHearing DisordersNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsDeafnessHearing Loss, ConductiveHearing Loss

Criteria

3 inclusion criteria required to participate
Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz < 30 decibel (dB) hearing level (HL)
Signed informed consent
Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz < 30 dB hearing level (HL) in the best ear
8 exclusion criteria prevent from participating
Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
Condition that may have an impact on the outcome of the investigation as judged by the investigator
Less than 4mm of soft tissue pre-operatively
Participation in another investigation with pharmaceuticals and/or device
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

The HEARing CRC &amp; HearWorks, University of Melbourne

Melbourne, AustraliaOpen The HEARing CRC &amp; HearWorks, University of Melbourne in Google Maps

Clinica Las Condes

Santiago, Chile

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Bnai Zion MedicalCenter

Haifa, Israel
Completed4 Study Centers