Clinical trial NCT03859648: BONEBRIDGE Bone Conduction Implant in Adults
Official title: Outcomes in Adults With Mixed or Conductive Hearing Loss Implanted With the BONEBRIDGE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss, Conductive
Hearing Loss, Mixed
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number and Proportion of Subjects Experiencing Device Related Adverse Events
timeFrame: Up to three (3 months) post activation
measure: Percentage Change in AZ Bio Sentence Score in Noise
timeFrame: Baseline and 3 months post activation
Secondary outcomes:
measure: Percentage Change in CNC Word Score
timeFrame: Baseline and 3 months post activation
measure: Number of Subjects With Stable or Better Soundfield Thresholds
timeFrame: Baseline and 3 months post activation
measure: Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance
timeFrame: Baseline and 3 months post activation
measure: Number of Subjects With Stable Unaided Bone Conduction Thresholds
timeFrame: Baseline and 2 weeks post surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Wexner Medical Center University
state: Ohio
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
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.
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.
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.
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.
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.
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.