BONEBRIDGE Bone Conduction Implant in Adults

Hearing Loss, Conductive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03859648
• Other study ID #: MED-EL BB
• Status: Terminated
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: November 4, 2022

Study information

• Verified date: May 2024
• Source: Med-El Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed
• Hearing Loss, Mixed Conductive-Sensorineural

Intervention

Device:
• BONEBRIDGE
Bone Conduction Implant

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
United States	The Ohio State Wexner Medical Center University	Columbus	Ohio
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage Change in CNC Word Score	Percent improvement in CNC word scores will be compared from baseline to 3 months post activation.	Baseline and 3 months post activation
Secondary	Number of Subjects With Stable or Better Soundfield Thresholds	The number of subjects with stable or better aided soundfield thresholds at 3 months post activation compared to baseline unaided soundfield thresholds	Baseline and 3 months post activation
Secondary	Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance	The number of subjects with similar or better performance on the QuickSIN (Speech In Noise) task in the implanted ear compared to baseline performance	Baseline and 3 months post activation
Secondary	Number of Subjects With Stable Unaided Bone Conduction Thresholds	The number of subjects with stable bone conduction thresholds at the device activation interval compared to pre-operative bone conduction thresholds.	Baseline and 2 weeks post surgery