(59 days)
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No
The document explicitly states the device uses "analog signal processing" and there are no mentions of AI, ML, or related terms.
No
The device is a sound processor intended to amplify and process sound for individuals with hearing loss, but it does not directly treat or cure a disease; it assists with a physical impairment.
No
Explanation: The device is a sound processor designed to amplify and process sound for individuals with hearing loss, not to diagnose a medical condition. It is a therapy device that helps patients with hearing impairments.
No
The device description explicitly states that the Baha system combines a sound processor with an abutment and a titanium implant, indicating it is a hardware-based medical device. The Cordelle II is described as a "sound processor," which is a physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Baha Cordelle II sound processor is a hearing aid system that works by conducting sound through bone to the cochlea. It processes sound from the environment and transmits it to the inner ear.
- Intended Use: The intended use is to improve hearing for individuals with specific types of hearing loss. This is a therapeutic and assistive function, not a diagnostic one based on analyzing biological specimens.
The device description and intended use clearly indicate that this is a device used to treat or manage hearing loss by providing sound amplification and transmission, not to diagnose a condition by analyzing samples from the body.
N/A
Intended Use / Indications for Use
The Baha Cordelle II sound processor is intended for use with the Baha auditory osseointegrated implant 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 65 dB HL.
- Bilateral fitting of the Cordelle II is intended for patients who meet the above e 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 air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
Product codes (comma separated list FDA assigned to the subject device)
LXB
Device Description
The Baha 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.
The Cordelle II is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the only analog signal processing and body-worn sound processor, and it offers the highest power output of all the devices.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skull bone
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 Cordelle II for the expanded audiometric fitting range in the proposed revised Indications for Use statement (van der Pouw et al., 1998: Tiellstrom et al., 2001; Bosman et al., 2006; studies that were not sponsored by the applicant). The published data illustrate that the Cordelle II provides higher gain and maximum output levels than the other sound processors in the Baha family, and that patients with greater (more severe) degrees of bone-conduction hearing loss than previously cleared for marketing in the United States can also significantly benefit from the Cordelle II.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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) Summary
APR 1 0 2008
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 400 Inverness Parkway, Suite 400 Englewood, CO 80112
On behalf of:
Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14 SE-435 33 Mölnlycke Sweden
Contact Person:
Sean Bundy Manager, Regulatory Affairs Phone: 303-524-7139 (office) 303-792-9025 (facsimile) Email: SBundy@cochlear.com
Date Submission Prepared:
January 21, 2008
Device Name:
Baha® Cordelle II Trade or Proprietary Name: Hearing Aid (Bone Conduction) Common or Usual Name: Class II, 21 CFR §874.3300 Classification Status: Product Codes: LXB
Panel:
Ear Nose and Throat Specialty Panel
1
Predicate Devices
The design, manufacturing, function and fitting procedure of the Baha Cordelle II have not changed since it was originally cleared for marketing under 510(k) K992872. This submission is intended only for an expanded Indications for Use statement for this sound processor based on the additional gain/output it supplies relative to the other sound processors in the Baha family, and on published clinical data. See Table 2 under Section X 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.
Device Description
The Baha 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.
The Cordelle II is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the only analog signal processing and body-worn sound processor, and it offers the highest power output of all the devices.
Intended Use
The Baha system is indicated for patients who have conductive or mixed hearing loss, and 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; SSD), and patients who are candidates for an air-conduction contralateral routing of signals (AC CROS) hearing aid but who for some reason cannot or will not wear an AC CROS device.
Patients (either by themselves or with the aid of others) must be able to maintain hygiene of the abutment/skin interface of the Baha. They should also have sufficient bone volume and bone quality to support successful fixture placement.
Under 510(k) K992872, the Baha Cordelle II was cleared for marketing for conductive and mixed hearing loss patients with average bone-conduction thresholds of