BONEBRIDGE Bone Conduction Implant in Adults

Overview

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.

Full Title of Study: “Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 4, 2022

Interventions

  • Device: BONEBRIDGE
    • Bone Conduction Implant

Arms, Groups and Cohorts

  • Experimental: Bone Conduction Implant
    • All subjects will be implanted with the bone conduction implant.

Clinical Trial Outcome Measures

Primary Measures

  • Number and proportion of subjects experiencing device related adverse events
    • Time Frame: Up to three (3 months) post activation
    • 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
    • Time Frame: Up to three (3 months) post activation
    • 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 Measures

  • Percent correct words recognition in quiet in implanted ear.
    • Time Frame: Up to three (3 months) post activation
    • 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
    • Time Frame: Up to three (3 months) post activation
    • Subjects will demonstrate similar or better soundfield thresholds in the implanted ear compared to preoperative performance
  • Signal to noise ratio in the implanted ear
    • Time Frame: Up to three (3 months) post activation
    • 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
    • Time Frame: Up to two (2 weeks) post operative evaluation
    • Subjects will demonstrate stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Med-El Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

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.

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.

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.