BONEBRIDGE Bone Conduction Implant in Adults

NCT03859648 | Terminated Results FDA Device

• 1 other identifier: MED-EL BB
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 3

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.

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed

Outcome Measures

Primary Outcomes (2)

• Number and Proportion of Subjects Experiencing Device Related Adverse Events

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

  Up to three (3 months) post activation

• Percentage Change in AZ Bio Sentence Score in Noise

  Percent improvement in AZ Bio sentence in noise scores will be compared from baseline to 3 months post activation.

  Baseline and 3 months post activation

Secondary Outcomes (4)

• Percentage Change in CNC Word Score

  Baseline and 3 months post activation

• Number of Subjects With Stable or Better Soundfield Thresholds

  Baseline and 3 months post activation

• Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance

  Baseline and 3 months post activation

• Number of Subjects With Stable Unaided Bone Conduction Thresholds

  Baseline and 2 weeks post surgery

Study Arms (1)

Bone Conduction Implant

EXPERIMENTAL

All subjects will be implanted with the bone conduction implant.

Device: BONEBRIDGE

Interventions

BONEBRIDGE DEVICE

Bone Conduction Implant

Bone Conduction Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (3)

The Ohio State Wexner Medical Center University

Columbus, Ohio, 43081, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (6)

• 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.

  PMID: 16868513 BACKGROUND

• 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.

  PMID: 25142577 BACKGROUND

• 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.

  PMID: 27475796 BACKGROUND

• 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.

  PMID: 26073720 BACKGROUND

• 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.

  PMID: 23714710 BACKGROUND

• 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.

  PMID: 26491482 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: MED-EL Corporation
• Organization: MED-EL Corporation

research.us@medel.com

919-314-1437

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 12, 2019
• First Posted: March 1, 2019
• Study Start: August 26, 2019
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)