(65 days)
No
The document describes a modification to a sound processor, primarily focusing on replacing an ASIC with an off-the-shelf electronic assembly and compatibility with 2.4GHz devices. There is no mention of AI or ML in the intended use, device description, or any of the provided sections.
Yes
The device is intended to treat hearing loss by amplifying and conducting sound to the cochlea, which is a therapeutic function.
No
The device is a sound processor designed to amplify and transmit sound to aid individuals with hearing loss, not to diagnose a condition.
No
The device description clearly states that the Baha 4 sound processor is a modification to a physical sound processor (BP100) and includes an electronic assembly. It is a hardware device with software components, not a software-only device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Cochlear Baha 4 sound processor is a hearing aid system that works by conducting sound through bone to the cochlea. It is a device that is worn externally or connected to an implant, and it processes sound from the environment.
- Lack of Sample Analysis: The description clearly states how the device works (transcutaneous bone conduction or osseointegration) and its purpose (amplifying and processing sound for individuals with hearing loss). There is no mention of analyzing biological samples from the patient.
Therefore, the Cochlear Baha 4 sound processor falls under the category of a hearing aid or auditory prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cochlear Baha® 4 sound processor has the following indications for use:
- . Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
- . 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 is intended for patients who meet the 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; 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
LXB
Device Description
The subject of this Special 510(k): Device Modification is a modification to the Cochlear BP100 sound processor, which was cleared under 510(k) K090720 for unilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 100,000 users of a Baha system globally.
Baha sound processors can be used with either the external Baha headband or Softband in persons of any age, or for children aged 5 or older with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. 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 surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via the skull bone directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.
The modified sound processor, the Baha 4 is an upgrade to the currently marketed Baha BP100 sound processor, which it will replace on the U.S. market. The Baha 4 sound processor is mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-theshelf electronic assembly used in currently marketed air conduction devices. The modified device utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device it will replace. In addition, the Baha 4 is compatible with certain 2.4GHz devices currently marketed for use with air conduction hearing aids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K002913, K100360, K121317, K955713
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 13059 East Peakview Ave. Centennial, CO 80111
SEP 26 2013
On behalf of:
Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14 SE-435 33 Mölnlycke Sweden
Contact Persons:
Sean Bundy Sr. Manager, Regulatory Affairs and Compliance Phone: 303-524-7139 Facsimile: 303-524-6825 Email: SBundy@cochlear.com
Date Submission Prepared:
July 2013
Device Name:
Trade or Proprietary Name: Common or Usual Name: Classification Status: Product Codes: Panel:
Cochlear Baha® 4 Sound Processor Bone Anchored Sound Processor Class II, 21 CFR §874.3300 LXB Ear Nose and Throat Devices Panel
Cochlear Baha 4 Sound Processor – Special 510(k)
1
Device Description:
The subject of this Special 510(k): Device Modification is a modification to the Cochlear BP100 sound processor, which was cleared under 510(k) K090720 for unilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 100,000 users of a Baha system globally.
Baha sound processors can be used with either the external Baha headband or Softband in persons of any age, or for children aged 5 or older with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. 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 surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via the skull bone directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.
The modified sound processor, the Baha 4 is an upgrade to the currently marketed Baha BP100 sound processor, which it will replace on the U.S. market. The Baha 4 sound processor is mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-theshelf electronic assembly used in currently marketed air conduction devices. The modified device utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device it will replace. In addition, the Baha 4 is compatible with certain 2.4GHz devices currently marketed for use with air conduction hearing aids.
Intended Use:
The new Baha 4 will be used as an external sound processor option (in the Cochlear Baha family of sound processors) to conduct sound energy directly to the cochlea via a Baha auditory osseointegrated implant, or via transcutaneous transmission with a Baha headband or Softband. This is the same intended use, and for the same patient population, as the current legally marketed, unmodified Baha BP100 device (the predicate device that it will replace).
2
Technological Characteristics:
The modified sound processor will still be compatible with the currently marketed Softband/headband (cleared under K002913 and letters to file under this clearance), and the currently marketed auditory osseointegrated implant (BIA300 system, cleared under K100360 and BA400 cleared under K121317), and will also be backward compatible with the original auditory osseointegrated implant (cleared under K955713).
The primary modifications proposed are technological improvements so that the Baha 4 can take advantage of several features that are inherent to the new electronic assembly. These include:
- 2.4GHz wireless audio and data connection capability .
- One additional program slot (for a total of 4) .
- Wind noise detection and reduction .
- 17-channel sound analysis .
- . Automatic scene analysis
The Baha Fitting Software (also cleared under K090720) has been updated to incorporate support for communication with the new electronic assembly, as well as allowing the fitting audiologist to enable or disable features of the new electronic assembly.
Conclusions:
Despite technological improvements and the upgrade to new sound processing features, the Baha 4 sound processor still has substantially equivalent function and technology, and the same intended use as the predicate Baha BP100 sound processor cleared for marketing under K 090720. The indication for use statement is also the same as that for the current legally marketed Baha BP100 sound processor that it will replace.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-C760 Silver Spring, MD 20993-0002
September 26,2013
Cochlear Americas % Mr. Sean Bundy Director, Regulatory Strategy, Cochlear Americas 13059 E Peakview Ave Centennial, CO 80111
Re: K132278
Trade/Device Name: Baha 4 Sound Processor Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: August 27, 2013 Received: August 27, 2013
Dear Mr. Bundy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Sean Bundy
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-
free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known): K 132278
Device Name: Cochlear Baha 4 Sound Processor
Indications for Use Statement:
The Cochlear Baha® 4 sound processor has the following indications for use:
- . Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
- . 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 is intended for patients who meet the 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; 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.
Prescription Use X
Over-The-Counter Use --------AND/OR
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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