NCT01822119

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
4 countries

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

February 6, 2017

Completed
Last Updated

February 6, 2017

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

March 19, 2013

Results QC Date

August 24, 2016

Last Update Submit

December 12, 2016

Conditions

DeafnessHearing LossHearing Loss, Conductive

Outcome Measures

Primary Outcomes (2)

  • Hearing Performance, PTA4 at 12 Weeks

    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.

    Baseline before surgery and 12 weeks after surgery

  • Hearing Performance, PTA4 at 36 Weeks

    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

    Baseline before surgery and 36 weeks after surgery

Secondary Outcomes (8)

  • Hearing Performance, Individual Frequencies

    Baseline before surgery and 36 weeks after surgery

  • Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks

    Baseline before surgery and 36 weeks after surgery

  • Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks

    Baseline before surgery and 36 weeks after surgery

  • Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks

    Baseline before surgery and 36 weeks after surgery

  • Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks

    Baseline before surgery and 36 weeks after surgery

  • +3 more secondary outcomes

Other Outcomes (10)

  • Time to Perform Surgery

    Visit 2 (surgery)

  • Tissue Reduction Performed During Surgery

    Visit 2 (surgery)

  • Implant Stability

    Visit 2 (surgery)

  • +7 more other outcomes

Study Arms (1)

Baha Attract System

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)

Device: Baha Attract System

Interventions

Baha Attract SystemDEVICE
Baha Attract System

Eligibility Criteria

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

You may qualify if:

  • 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)
  • 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
  • Signed informed consent

You may not qualify if:

  • Uncontrolled diabetes as judged by the investigator
  • Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
  • Unable to follow investigational procedures, e.g. to complete quality of life scales
  • Less than 4mm of soft tissue pre-operatively
  • Participation in another investigation with pharmaceuticals and/or device
  • Condition that may have an impact on the outcome of the investigation as judged by the investigator
  • Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
  • Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The HEARing CRC & HearWorks, University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Clinica Las Condes

Santiago, Chile

Location

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Bnai Zion MedicalCenter

Haifa, 31048, Israel

Location

Related Publications (1)

  • Briggs R, Van Hasselt A, Luntz M, Goycoolea M, Wigren S, Weber P, Smeds H, Flynn M, Cowan R. Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol. 2015 Jun;36(5):834-41. doi: 10.1097/MAO.0000000000000712.

    PMID: 25634465RESULT

MeSH Terms

Conditions

DeafnessHearing LossHearing Loss, Conductive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Professor Robert Cowan
Organization
The HEARing CRC & Hearworks, Audiology Hearing and Speech Science, Melbourne, Australia
r.cowan@unimelb.edu.au
+61 3 9035 5346

Study Officials

  • Robert Cowan, A/Professor

    The HEARing CRC & HearWorks, University of Melbourne

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

April 2, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 6, 2017

Results First Posted

February 6, 2017

Record last verified: 2016-12

Locations

AU(1)HK(1)IL(1)CL(1)