NCT02722330

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 17, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

February 17, 2016

Results QC Date

February 1, 2018

Last Update Submit

February 20, 2019

Conditions

Single Sided Sensorineural DeafnessMixed Hearing Loss, Unilateral

Outcome Measures

Primary Outcomes (1)

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

    Change of hearing performance PTA4 \[Mean of 0.5, 1, 2 and 4 kHz\] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks

    12 weeks

Secondary Outcomes (21)

  • Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.

    12 weeks

  • Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.

    12 weeks

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

    4 weeks

  • Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided

    4 weeks

  • Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided

    12 weeks

  • +16 more secondary outcomes

Other Outcomes (1)

  • Number of Adverse Events Related to the Treatment

    12 weeks

Study Arms (1)

Baha 5 SuperPower on Baha Attract System

EXPERIMENTAL

The device involves the following parts: The sound processor unit, an actuator unit and a cable, the Sound Processor Magnet (SP Magnet) of the Baha Attract System, the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant, a snap coupling.

Device: Baha 5 SuperPower on Baha Attract System

Interventions

Baha 5 SuperPower on Baha Attract SystemDEVICE

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.

Baha 5 SuperPower on Baha Attract System

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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 and/or wound healing (e.g. osteoporosis, psoriasis and long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
  • Unable to follow investigational procedures, e.g. to complete quality of life scales.
  • Participation in another clinical investigation with pharmaceutical and/or device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Antwerp University Hospital

Antwerp, Belgium

Location

Odense University Hospital

Odense, Denmark

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Professor Jaydip Ray
Organization
ENT Department, Royal Hallamshire Hospital, Sheffield
jaydip.Ray@sth.nhs.uk
+44 (0)114 271 1900

Study Officials

  • Jaydip Ray, Professor

    Royal Hallamshire Hospital

    PRINCIPAL INVESTIGATOR

  • César Orús, Dr

    Hospital de Sant Pau

    PRINCIPAL INVESTIGATOR

  • Paul Van de Heyning, Professor

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Jesper Schmidt, Dr

    Odense University Hospital

    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
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

March 30, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 3, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-02

Locations

ES(1)BE(1)GB(1)DK(1)