(522 days)
The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications:
- Patients 12 years of age or older.
- Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL.
- . Bilateral fitting of the BONEBRIDGE is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.
- Patients who have profound sensorineural hearing loss in one ear and normal hearing . in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
- . The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
- . Prior to receiving the device, it is recommended that an individual have experience with appropriately fit air conduction or bone conduction hearing aids.
The BONEBRIDGE consists of a Bone Conduction Implant that is surgically implanted in the mastoid bone and an external Audio Processor that is held in place on the patient's scalp by magnetic attraction between the implant and the Audio Processor (Figure 1).
Here's a breakdown of the acceptance criteria and the study data provided for the BONEBRIDGE™ System:
The BONEBRIDGE™ System did not undergo a study to prove meeting "acceptance criteria" in the traditional sense of a classification algorithm with performance metrics like sensitivity, specificity, or AUC. Instead, it underwent a series of non-clinical (bench) and clinical studies to demonstrate its safety and effectiveness for its intended use as an active implantable bone conduction hearing system.
The acceptance criteria are therefore defined by the successful demonstration of:
- Biocompatibility of all components.
- Sterilization and Shelf Life validation.
- Electrical Safety and Electromagnetic Compatibility (EMC), including wireless compatibility.
- Software (SYMFIT) verification and validation at a "Minor" Level of Concern.
- Performance Testing (Bench) for the Audio Processor (SAMBA BB) and the Bone Conduction Implant (BCI 601) and surgical tools.
- Clinical Effectiveness for conductive/mixed hearing loss and single-sided deafness.
- Clinical Safety in terms of adverse events and maintenance of bone conduction thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device, the "acceptance criteria" and "reported device performance" are largely based on meeting pre-defined thresholds and "passing" various tests to demonstrate safety and functional specifications.
| Category | Acceptance Criteria (Design Requirement/Objective) | Reported Device Performance (Result) |
|---|---|---|
| Biocompatibility | All patient-contacting components to be biocompatible per ISO 10993 standards. | All components (SAMBA BB, BCI 601, BCI Lifts, Surgical Tools) passed all specified biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Implantation, Genotoxicity, Subchronic Toxicity, Carcinogenicity, Pyrogenicity, Exhaustive Extraction, Particulate Matter). |
| Sterilization & Shelf Life | Sterilization validation per AAMI/ANSI/ISO 11135:2014; Shelf life validation for sterility and integrity per ISO 11607-1:2006. | BCI 601, surgical tools, and BCI Lifts/Sizer Kit sterilization validated (EO sterilization, overkill approach). Packaging of sterile components validated for shelf life, sterility, and integrity. SAMBA BB is non-sterile. |
| Electrical Safety & EMC | Meet IEC 60601-1-2 EMC standards, ANSI C63.19 wireless compatibility, electrical safety per IEC 60601-1, leakage current/voltage difference. | All acceptance criteria were met for EMC (with SAMBA BB), wireless compatibility, and electrical safety (BCI 601 and SAMBA BB). Minor reported issue of "parasitic demodulation" mitigated by labeling instructions. |
| MR Compatibility | N/A (Device is identified as MR Unsafe, which is an accepted characteristic rather than a performance criterion) | MR Unsafe. |
| Software | SYMFIT software to be verified, validated, and hazard analyzed at "Minor" Level of Concern. | Software description, hazard analysis, traceability, verification/validation, and revision history were addressed. SYMFIT is standalone and does not affect safety; failure only impacts programming. |
| Bench Performance (SAMBA BB) | Force Output: > Max Power Output (MPO) at specific frequencies (e.g., 90 dB μN at 500 Hz). | |
| Transmission Scheme: Difference between force output at 7mm and 4mm coupling distance ≤ 4 dB. | ||
| Battery Lifetime: > 16 hours. | ||
| Noise Floor: 16 hours), and noise floor ( |
§ 874.3340 Active implantable bone conduction hearing system.
(a)
Identification. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Performance data must validate force output in a clinically relevant model.
(ii) Impact testing in a clinically relevant anatomic model must be performed.
(iii) Mechanical integrity testing must be performed.
(iv) Reliability testing consistent with expected device life must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Labeling must include:
(i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events;
(ii) Instructions for use;
(iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions;
(iv) A shelf life, for device components provided sterile;
(v) A patient identification card; and
(vi) A patient user manual.