BONEBRIDGE Bone Conduction Implant in Adults

Study Overview
=================
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.

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

Conditions
-----------------
Hearing Loss, Conductive, Hearing Loss, Mixed

Intervention / Treatment
-----------------
* Device: BONEBRIDGE


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone Conduction Implant<br>All subjects will be implanted with the bone conduction implant. | Device: BONEBRIDGE<br>* Bone Conduction Implant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percent correct of words identified for sentences in noise in implanted ear | 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. | Up to three (3 months) post activation | 

Secondary Outcome Measures

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