(91 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on sound processing and osseointegration, not AI/ML algorithms.
Yes
The device is intended to compensate for hearing loss and improve sound perception, which are therapeutic effects addressing a medical condition.
No
The device is a sound processor intended to amplify and process sound for individuals with hearing loss. It does not diagnose medical conditions.
No
The device description clearly states that the device is a "sound processor" that works in conjunction with a titanium implant or external bone-conduction vibrators (Headband/Softband). These are hardware components, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Cochlear Baha BP100 is a sound processor designed to improve hearing by conducting sound through bone to the cochlea. It is a hearing aid system.
- Lack of Biological Sample Testing: The description clearly outlines how the device works by processing sound and transmitting vibrations through bone. There is no mention of analyzing biological samples.
Therefore, the function and intended use of the Cochlear Baha BP100 fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Cochlear Baha BP100 sound processor is intended for use with the Baha auditory osseointegrated implant (for children aged 5 and older, or adults), or with the Baha Headband or Baha Softband (no age limitations), for the following patients and indications:
- Patients who have a conductive or mixed hearing loss and can still benefit from . sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL.
- Bilateral fitting of the BP100 is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
- Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. single-sided deafness or "SSD"). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
- Baha for SSD is also indicated for any patient who is indicated for an airconduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
Product codes
LXB
Device Description
The Baha implant system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality. Baha sound processors can also be fitted as external (non-implanted) bone-conduction vibrators with either the Baha Headband or Baha Softband as an alternative to a conventional bone-conduction hearing aid.
The Baha BP100 will be the newest addition to a current family of three marketed sound processors for use with the Baha auditory osseointegrated implant, or with the Baha Headband/Softband setup. In its initial release, it will provide a moderate gain ear-level sound processor that will serve as a premium-feature option to the currently marketed Baha Divino. At a later date, the BP100 platform may be used to provide a range of programmable products to meet end-user needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skull behind the ear, Cochlea
Indicated Patient Age Range
For the Baha auditory osseointegrated implant: children aged 5 and older, or adults.
For the Baha Headband or Baha Softband: no age limitations.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Published data in the literature support the safety and efficacy of the Baha Divino for patients with average bone-conduction thresholds of
§ 874.3302 Bone-conduction hearing aid.
(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.
0
Cochlear Americas
510(k) Premarket Notification Cochlear Baha BP100
510(k) Summary
JUN 1 7 2009
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided.
Submitted by:
Cochlear Americas 13059 East Peakview Ave. Centennial, CO 80111
On behalf of:
Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14 SE-435 33 Mölnlycke Sweden
Contact Persons:
Sean Bundy Manager, Regulatory Affairs Phone: 303-524-7139 (office) 303-792-9025 (facsimile) Email: SBundy@cochlear.com
Carol A. Sammeth, Ph.D., CCC-A/FAAA Senior Regulatory/Clinical Specialist Phone: 303-524-6833 (office) Email: CSammeth@cochlear.com
Date Submission Prepared:
March 2009
Device Name:
| Trade or Proprietary Name: | Cochlear Baha® BP100 |
|---|---|
| Common or Usual Name: | Hearing Aid (Bone Conduction) |
| Classification Status: | Class II, 21 CFR §874.3300 |
| Product Codes: LXB | |
| Panel: | Ear Nose and Throat Specialty Panel |
Panel:
1
Predicate Devices
The predicate devices for the Baha BP100 sound processor are the three currently marketed sound processors in the family of processors available for use with the Baha® auditory osseointegrated implant; namely, the Baha Divino™ (510(k) K042017), Baha IntensoTM (510(k) K081606), and Baha Cordelle II (510(k) K080363). Bench testing shows that the gain/output of the Baha BP100 are comparable to those for the marketed Baha Divino sound processor, and the intended use and technological characteristics of the Baha BP100 are substantially equivalent to the other three marketed sound processors. See Table 2 under Section XI of this submission for a detailed comparison of technological characteristics and features across the Baha family of sound processors used with the auditory osseointegrated implant.
Unique to the new Baha BP100 sound processor is that it can be programmed with fitting software, as well as manually adjusted like the predicate devices. The programming software and interface (described in Section XV of this submission) is substantially equivalent to other programming software that has been used for fitting of hearing devices that have digital signal processing algorithms. The fitting software, used on a standard computer, interfaces with the sound processor via cables to a standard HI-PRO box or NOAH-link, and has the same intended use and works in the same manner as that of many programmable hearing aids and devices. Predicate devices proposed for the fitting software system are 510(k) number K973880 for the Sonix hearing aid fitting and programming system, 510(k) number K931372 for the Resound® portable prescriptive programming system, and 510(k) number K942749 for the HI-PRO/NOAH universal hearing instrument by Madsen Electronics.
Also unique to this new Baha sound processor is the ability to measure bone-conduction thresholds directly via pure tones generated by the sound processor. The intended use and process to accomplish these measurements is also substantially equivalent to a procedure used by a previous hearing device cleared for marketing under the 510(k) process. Specifically, the predicate for obtaining data to assist in more accurate fittings by obtaining measurements for pure tones produced by the hearing device can be found in 510(k) number K984547 for the LGOB test using the Resound® digital 5000 series hearing devices. Although that approach uses suprathreshold measures to determine perceived loudness and the BP100 direct bone conduction measurements use threshold-level stimuli, the production of pure tones through the hearing device for standard audiometric measurements to be used in a prescription has the same intended use, function, and technology as the predicate.
Device Description
The Baha implant system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the
2
Cochlear Americas
510(k) Premarket Notification Cochlear Baha BP100
implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality. Baha sound processors can also be fitted as external (non-implanted) bone-conduction vibrators with either the Baha Headband or Baha Softband as an alternative to a conventional bone-conduction hearing aid.
The Baha BP100 will be the newest addition to a current family of three marketed sound processors for use with the Baha auditory osseointegrated implant, or with the Baha Headband/Softband setup. In its initial release, it will provide a moderate gain ear-level sound processor that will serve as a premium-feature option to the currently marketed Baha Divino. At a later date, the BP100 platform may be used to provide a range of programmable products to meet end-user needs.
Intended Use
The Baha system is indicated for patients who have conductive or mixed hearing loss, and who can still benefit from sound amplification. Patients with bilaterally symmetric conductive or mixed hearing loss may be implanted bilaterally. The Baha system is also indicated for patients with sensorineural deafness in one ear and normal hearing in the other ear (i.e. single-sided deafness or "SSD"), and patients who are candidates for an airconduction contralateral routing of signals (AC CROS) hearing aid but who for some reason cannot or will not wear an AC CROS device.
For the Baha implant, patients must be > 5 years old (per 510(k) K984162). They also must (either by themselves or with the aid of others) be able to maintain hygiene of the abutment/skin interface of the Baha. Finally, they should have sufficient bone volume and bone quality to support successful fixture placement. For patients not meeting these criteria for implantation, the Baha sound processor can be fit externally (non-implanted) with the Baha Headband or Baha Softband for transcutaneous bone-conduction stimulation.
The BP100 offers gain/output that is comparable to that supplied by the currently marked Baha Divino sound processor. Thus, it will be marketed for use for conductive or mixed hearing loss patients who have average bone-conduction thresholds up to