Expanded Indications in the Pediatric BONEBRIDGE Population

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MED-EL BONEBRIDGE Bone Conduction Implant

About this trial

This is an interventional treatment trial for Hearing Loss, Conductive

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Under 12 years of age Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted Sufficient air-bone gap (ABG) at in the ear to be implanted HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons Parental commitment to comply with all study procedures Exclusion Criteria: Children under 3 years (36 months) of age Chronic or non-revisable vestibular or balance disorders Abnormally progressive hearing loss Prior use of a hearing implant in the ear to be implanted Current/ongoing use of a hearing implant in the contralateral/non-implant ear Evidence that hearing loss is retrocochlear in origin Medical condition that contraindicates implant surgery or anesthesia Skin or scalp condition precluding use of external audio processor

Sites / Locations

University of Colorado Health/Children's Hospital of ColoradoRecruiting
University of MiamiRecruiting
University Hospital Newark/Rutgers New Jersey Medical School
University of North CarolinaRecruiting
The Ohio State University/Nationwide Children's Hospital
University of Utah Health/Primary Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study procedure

Arm Description

This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.

Outcomes

Primary Outcome Measures

Functional gain

Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds

Adverse events

Number and proportion of subjects experiencing serious device- and surgery-related adverse events

Secondary Outcome Measures

Word recognition score

Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score

Unaided bone-conduction pure-tone average (BC-PTA)

Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA

Post-intervention quality-of-life questionnaire

Total and subscale scores on Glasgow Children's Benefit Inventory

Full Information

NCT ID

NCT05615649

First Posted

November 7, 2022

Last Updated

September 20, 2023

Sponsor

Med-El Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05615649

Brief Title

Expanded Indications in the Pediatric BONEBRIDGE Population

Official Title

Expanded Indications in the Pediatric BONEBRIDGE Population

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

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

No

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.

Detailed Description

This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.

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

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study procedure

Arm Type

Experimental

Arm Description

This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.

Intervention Type

Device

Intervention Name(s)

MED-EL BONEBRIDGE Bone Conduction Implant

Other Intervention Name(s)

BCI 602

Intervention Description

Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.

Primary Outcome Measure Information:

Title

Functional gain

Description

Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds

Time Frame

Up to six (6) months post-activation

Title

Adverse events

Description

Number and proportion of subjects experiencing serious device- and surgery-related adverse events

Time Frame

Up to six (6) months post-activation

Secondary Outcome Measure Information:

Title

Word recognition score

Description

Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score

Time Frame

Up to six (6) months post-activation

Title

Unaided bone-conduction pure-tone average (BC-PTA)

Description

Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA

Time Frame

Up to three (3) months post-activation

Title

Post-intervention quality-of-life questionnaire

Description

Total and subscale scores on Glasgow Children's Benefit Inventory

Time Frame

Up to six (6) months post-activation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Under 12 years of age Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted Sufficient air-bone gap (ABG) at in the ear to be implanted HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons Parental commitment to comply with all study procedures Exclusion Criteria: Children under 3 years (36 months) of age Chronic or non-revisable vestibular or balance disorders Abnormally progressive hearing loss Prior use of a hearing implant in the ear to be implanted Current/ongoing use of a hearing implant in the contralateral/non-implant ear Evidence that hearing loss is retrocochlear in origin Medical condition that contraindicates implant surgery or anesthesia Skin or scalp condition precluding use of external audio processor

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MED-EL Corporation

Phone

1-888-633-3524

Email

research.us@medel.com

Facility Information:

Facility Name

University of Colorado Health/Children's Hospital of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Gitomer, MD

Email

sarah.gitomer@childrenscolorado.org

First Name & Middle Initial & Last Name & Degree

Kristi Engle-Folchert

Email

KRISTI.ENGLEFOLCHERT@CUANSCHUTZ.EDU

First Name & Middle Initial & Last Name & Degree

Sarah Gitomer, MD

First Name & Middle Initial & Last Name & Degree

Kirsten Adkisson

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hillary Snapp, AuD, PhD

Email

HSnapp@med.miami.edu

First Name & Middle Initial & Last Name & Degree

Hillary Snapp, MD

Facility Name

University Hospital Newark/Rutgers New Jersey Medical School

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Jyung, MD

Email

jyungrw@njms.rutgers.edu

First Name & Middle Initial & Last Name & Degree

Robert Jyung, MD

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Morgan Selleck, MD

Email

anne_selleck@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Anne Selleck, MD

First Name & Middle Initial & Last Name & Degree

Caitlin Sapp

Facility Name

The Ohio State University/Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver Adunka, MD

Email

oliver.adunka@osumc.edu

First Name & Middle Initial & Last Name & Degree

Oliver Adunka, MD

Facility Name

University of Utah Health/Primary Children's Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil S Patel, MD

Email

neil.patel@hsc.utah.edu

First Name & Middle Initial & Last Name & Degree

Neil S Patel, MD

Hearing Loss, Conductive, Hearing Loss, Mixed

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial