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BONEBRIDGE Bone Conduction Implant in Adults

Primary Purpose

Hearing Loss, Conductive, Hearing Loss, Mixed

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

BONEBRIDGE

About this trial

This is an interventional treatment trial for Hearing Loss, Conductive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults, 18 years of age or older at the time of implantation
Conductive or mixed hearing loss, defined as:
Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz
Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz
Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz
Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better
Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears
Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
Able to complete testing materials in English
CT scan indicating the patient's anatomy is adequate to enable placement of the implant
Ability to undergo general anesthesia
Appropriate motivation and expectation levels
Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

Evidence that hearing loss is retrocochlear in origin
Skin or scalp condition precluding use of external audio processor
Suspected cognitive impairment or organic brain dysfunction

Sites / Locations

The Ohio State Wexner Medical Center University
The Hospital of the University of Pennsylvania
London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone Conduction Implant

Arm Description

All subjects will be implanted with the bone conduction implant.

Outcomes

Primary Outcome Measures

Number and proportion of subjects experiencing device related adverse events

Adverse events will be collected and reported throughout the duration of the study.

Percent correct of words identified for sentences in noise in implanted ear

AZBio sentence test recognition in noise scores will be calculated as percent correct of words in each sentence at unaided pre-operative performance through 3 months and reported as percentage points improved.

Secondary Outcome Measures

Percent correct words recognition in quiet in implanted ear.

CNC (Consonant Nucleus Consonant) words scores will be calculated as percent correct at unaided preoperative performance through 3 months and reported as percentage points improved.

Unaided soundfield thresholds

Subjects will demonstrate similar or better soundfield thresholds in the implanted ear compared to preoperative performance

Signal to noise ratio in the implanted ear

Subjects will demonstrate similar or better performance on the QuickSIN (Speech In Noise) in the implanted ear compared to preoperative performance.

Unaided bone conduction thresholds

Subjects will demonstrate stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.

Full Information

NCT ID

NCT03859648

First Posted

February 12, 2019

Last Updated

March 15, 2023

Sponsor

Med-El Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03859648

Brief Title

BONEBRIDGE Bone Conduction Implant in Adults

Official Title

Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment due to COVID-19

Study Start Date

August 26, 2019 (Actual)

Primary Completion Date

November 4, 2022 (Actual)

Study Completion Date

November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Med-El Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Conductive, Hearing Loss, Mixed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bone Conduction Implant

Arm Type

Experimental

Arm Description

All subjects will be implanted with the bone conduction implant.

Intervention Type

Device

Intervention Name(s)

BONEBRIDGE

Intervention Description

Bone Conduction Implant

Primary Outcome Measure Information:

Title

Number and proportion of subjects experiencing device related adverse events

Description

Adverse events will be collected and reported throughout the duration of the study.

Time Frame

Up to three (3 months) post activation

Title

Percent correct of words identified for sentences in noise in implanted ear

Description

Time Frame

Up to three (3 months) post activation

Secondary Outcome Measure Information:

Title

Percent correct words recognition in quiet in implanted ear.

Description

CNC (Consonant Nucleus Consonant) words scores will be calculated as percent correct at unaided preoperative performance through 3 months and reported as percentage points improved.

Time Frame

Up to three (3 months) post activation

Title

Unaided soundfield thresholds

Description

Subjects will demonstrate similar or better soundfield thresholds in the implanted ear compared to preoperative performance

Time Frame

Up to three (3 months) post activation

Title

Signal to noise ratio in the implanted ear

Description

Subjects will demonstrate similar or better performance on the QuickSIN (Speech In Noise) in the implanted ear compared to preoperative performance.

Time Frame

Up to three (3 months) post activation

Title

Unaided bone conduction thresholds

Description

Subjects will demonstrate stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.

Time Frame

Up to two (2 weeks) post operative evaluation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults, 18 years of age or older at the time of implantation Conductive or mixed hearing loss, defined as: Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons Able to complete testing materials in English CT scan indicating the patient's anatomy is adequate to enable placement of the implant Ability to undergo general anesthesia Appropriate motivation and expectation levels Stated willingness to comply with all study procedures for the duration of the study Exclusion Criteria: Evidence that hearing loss is retrocochlear in origin Skin or scalp condition precluding use of external audio processor Suspected cognitive impairment or organic brain dysfunction

Facility Information:

Facility Name

The Ohio State Wexner Medical Center University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43081

Country

United States

Facility Name

The Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16868513

Citation

Badran K, Bunstone D, Arya AK, Suryanarayanan R, Mackinnon N. Patient satisfaction with the bone-anchored hearing aid: a 14-year experience. Otol Neurotol. 2006 Aug;27(5):659-66. doi: 10.1097/01.mao.0000226300.13457.a6.

Results Reference

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PubMed Identifier

25142577

Citation

Riss D, Arnoldner C, Baumgartner WD, Blineder M, Flak S, Bachner A, Gstoettner W, Hamzavi JS. Indication criteria and outcomes with the Bonebridge transcutaneous bone-conduction implant. Laryngoscope. 2014 Dec;124(12):2802-6. doi: 10.1002/lary.24832. Epub 2014 Aug 20.

Results Reference

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PubMed Identifier

27475796

Citation

Schmerber S, Deguine O, Marx M, Van de Heyning P, Sterkers O, Mosnier I, Garin P, Godey B, Vincent C, Venail F, Mondain M, Deveze A, Lavieille JP, Karkas A. Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. Eur Arch Otorhinolaryngol. 2017 Apr;274(4):1835-1851. doi: 10.1007/s00405-016-4228-6. Epub 2016 Jul 30.

Results Reference

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PubMed Identifier

26073720

Citation

Sprinzl GM, Wolf-Magele A. The Bonebridge Bone Conduction Hearing Implant: indication criteria, surgery and a systematic review of the literature. Clin Otolaryngol. 2016 Apr;41(2):131-43. doi: 10.1111/coa.12484. Epub 2016 Feb 4.

Results Reference

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PubMed Identifier

23714710

Citation

Sprinzl G, Lenarz T, Ernst A, Hagen R, Wolf-Magele A, Mojallal H, Todt I, Mlynski R, Wolframm MD. First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy. Otol Neurotol. 2013 Aug;34(6):1076-83. doi: 10.1097/MAO.0b013e31828bb541.

Results Reference

background

PubMed Identifier

26491482

Citation

Zernotti ME, Sarasty AB. Active Bone Conduction Prosthesis: Bonebridge(TM). Int Arch Otorhinolaryngol. 2015 Oct;19(4):343-8. doi: 10.1055/s-0035-1564329.

Results Reference

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BONEBRIDGE Bone Conduction Implant in Adults

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