(83 days)
K042017 (Baha Divino)
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No
The document describes digital signal processing and active feedback cancellation, which are standard audio processing techniques, not necessarily AI/ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.
Yes
The device is intended to treat hearing loss by amplifying sound and conducting it to the cochlea, which is a therapeutic function.
No
This device is an external sound processor intended for use with an auditory osseointegrated implant or headband to amplify and process sound for individuals with hearing loss. It does not diagnose medical conditions.
No
The device description clearly states it is an "external sound processor" and describes its physical components and how it interacts with an implant or headband, indicating it is a hardware device with embedded 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 provide information about a person's health.
- Device Function: The Baha Intenso™ sound processor is a device that amplifies and transmits sound through bone conduction to improve hearing. It interacts with the patient's body physically (via an implant or headband) to deliver sound, not to analyze biological samples.
- Intended Use: The intended use clearly describes treating hearing loss by providing sound amplification, not by performing diagnostic tests on biological specimens.
The device description and intended use focus on the mechanical and auditory functions of the device in addressing hearing loss, which is outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Baha Intenso™ sound processor is intended for use with the Baha auditory osseointegrated implant or Baha Headband 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 55 dB HL.
- Bilateral fitting of the Intenso 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 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 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. The Baha implant is cleared for use in children aged 5 and older, and in adults.
The Intenso is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the highest gain ear-level sound processor currently available, although the maximum output is less than that for the high-power body-worn sound processor.
Baha sound processors, including the Intenso, can also be used with the Baha Headband (or Softband). In this application there is no implantation surgery: Rather, the sound processor is attached firmly to the head using either the hard or soft headband, and the amplified vibrational sound is transmitted transcutaneously to the bones of the skull for transmission to the cochlea. The Baha Headband is suitable for use in patients of all ages.
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
Ear, cochlea, skull bone
Indicated Patient Age Range
The Baha implant is cleared for use in children aged 5 and older, and in adults.
The Baha Headband is suitable for use in patients of all ages.
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)
Bench testing supports an expanded bone-conduction hearing threshold range in the Indications for Use statement for the Baha Intenso, so that more patients can benefit from this technology.
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.
K042017 (Baha Divino)
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).
Not Found
§ 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
K21666
AUG 2 8 2008
510(k) Summary
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:
May, 2008
Device Name:
| Trade or Proprietary Name: | Baha® Intenso™ |
|---|---|
| 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 |
1
Predicate Devices
The design, manufacturing, function and fitting procedure of the Baha Intenso™ have not changed since it was marketed in 2007 using a Letter To file under 510(k) K042017 (Baha Divino). This submission is intended only for an expanded Indications For Use for this sound processor. The proposed expanded indication is based on bench testing showing that the gain/output of the Baha Intenso is greater than that for the Baha Divino™ sound processor, although the maximum output is less than that for the high-power body-worn processor, the Baha Cordelle II. See Table 2 and Figures 1 and 2 under Section IX 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 or Baha Headband.
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. The Baha implant is cleared for use in children aged 5 and older, and in adults.
The Intenso is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the highest gain ear-level sound processor currently available, although the maximum output is less than that for the high-power body-worn sound processor.
Baha sound processors, including the Intenso, can also be used with the Baha Headband (or Softband). In this application there is no implantation surgery: Rather, the sound processor is attached firmly to the head using either the hard or soft headband, and the amplified vibrational sound is transmitted transcutaneously to the bones of the skull for transmission to the cochlea. The Baha Headband is suitable for use in patients of all ages.
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.
For the Baha implant system, 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.
2
Via Letter To File under 510(k) K042017 (Baha Divino), the Baha Intenso sound processor has to date been marketed for conductive and mixed hearing loss patients with average bone-conduction thresholds only up to