. 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.

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.

AI/ML Overview

The provided text describes the Baha® Cordelle II hearing aid, focusing on an expanded indication for use. Here's an analysis of the acceptance criteria and supporting studies based on the provided input:

Acceptance Criteria and Device Performance

The core of this submission is to expand the audiometric fitting range for the Baha Cordelle II. The original acceptance criterion for conductive and mixed hearing loss was a bone-conduction threshold of < 45 dB HL. The proposed expanded criterion is < 65 dB HL.

Acceptance Criteria (Expanded)	Reported Device Performance (Implied by supporting studies)
For patients with conductive or mixed hearing loss, 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. This replaces the previous standard of < 45 dB HL.	The Baha Cordelle II provides higher gain and maximum output levels than other Baha sound processors, allowing patients with bone-conduction hearing loss up to 65 dB HL to significantly benefit from the device. Studies show improved audiological outcomes for this expanded range.
For bilateral fitting, patients should 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.	Implied: The bilateral fitting performance is considered consistent with the expanded unilateral indication, as the symmetry criteria focus on suitability for bilateral application of the device's extended capabilities.
For patients with unilateral sensorineural deafness (SSD) in one ear with normal hearing in the other ear, "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. (This indication was already existing, and not explicitly changed in the context of the Cordelle II's expanded audiometric range, but included in the overall indications.)	Implied: The Cordelle II provides effective sound conduction for single-sided deafness, consistent with its general function for bone-anchored hearing, and is suitable for patients who cannot use AC CROS devices.
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. (This indication was already existing, and not explicitly changed in the context of the Cordelle II's expanded audiometric range, but included in the overall indications.)	Implied: As an alternative to AC CROS for SSD patients, the Cordelle II demonstrates its capability to route sound effectively in these cases.

Study Information for Device Performance

The submission relies on published clinical data to support the expanded indications for use.

Sample size used for the test set and the data provenance:
- The document refers to studies by van der Pouw et al. (1998), Tjellstrom et al. (2001), and Bosman et al. (2006). The specific sample sizes for these individual studies are not provided in the given text.
- Data Provenance: The studies are "published clinical data" and "studies that were not sponsored by the applicant." This suggests they are retrospective analyses of existing patient data or prospective clinical trials conducted independently of Cochlear Americas. The countries of origin for the data are not explicitly stated, but authors' affiliations in the references (e.g., Scandinavian Audiology, International Journal of Audiology, Otolaryngologic Clinics of North America) suggest an international context, likely including European data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the submission. Since the device is a hearing aid and the studies likely focus on audiological outcomes, the "ground truth" would implicitly be established through standard audiological assessments (e.g., pure tone audiometry, speech perception tests) conducted by qualified audiologists and/or ENT physicians, but the specific number or qualifications of these experts are not detailed in the context of establishing a specific ground truth for a test set for this submission.
Adjudication method for the test set:
- Not applicable / Not provided. The studies referenced are clinical performance studies, not typically involving an adjudication panel for a test set in the way an imaging AI algorithm might. The outcomes are based on measurable audiological data.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This is not an AI-based device, nor is it an imaging device requiring human reader interpretation. The studies focus on the direct clinical effectiveness of the device itself by measuring audiological improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Baha Cordelle II is a physical hearing aid that works in conjunction with a patient's auditory system. Its performance is measured in a human-in-the-loop context (i.e., when worn by a patient).
The type of ground truth used:
- The "ground truth" for these clinical studies implicitly relies on audiological outcome measures. This would include:
  - Pure-tone average bone-conduction thresholds.
  - Hearing level (dB HL) measurements.
  - Potentially speech recognition scores or other functional hearing assessments.
- These are considered clinical outcomes data directly reflecting the patient's hearing ability with the device.
The sample size for the training set:
- Not applicable. The Baha Cordelle II is an analog hearing aid, not a machine learning algorithm that requires a "training set." The device's design and functionality are based on established audiological principles and hardware, not iterative training on data.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in this context. The device's performance relies on its physical and electronic design to process sound effectively.

Summary

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K080363

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

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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

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 < 45 dB HL (across 0.5, 1, 2, and 3 kHz), the same indication as all other previously and currently marketed Baha sound processors. However, since the Cordelle II offers substantially higher gain and maximum output than the other devices, an expanded indication of < 65 dB HL is proposed with this submission.

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Technological Characteristics

Baha Cordelle II is an external sound processor that utilizes analog signal processing with K-Amp circuitry (Killion, 1993) for use with the Baha auditory osseointegrated implant. It has substantially equivalent technology to previously marketed sound processors for the Baha system (Baha Compact, Baha Classic 300) and to ther two currently marketed Baha sound processors (Baha Divino, Baha Intenso™). The external sound processors of the Baha system differ in style, signal processing, features, and degree of available gain and output, but they are all interchangeable in that they snap to the abutment of the Baha auditory osseointegrated implant. Choice of processor(s) depends on the individual needs and desires of the patient. The Cordelle II is often chosen for a patient who has greater gain needs since it offers the highest output levels and K-Amp circuitry that helps prevent saturation.

Non-Clinical Tests

The manufacturing and development process for the Baha Cordelle II is in compliance with ISO 13485 (Medical devices. Quality management systems. Requirements for regulatory purposes); ISO 11137 (Sterilization health care products. Requirements for validation and routine control. Radiation sterilization); ISO 14971 (Medical devices. Application of risk management to medical devices); EN 552 (Sterilization of medical devices. Validation and routine control of sterilization by irradiation); EN 868-1 (Packaging materials and systems for medical devices which are to be sterilized. Part 1: General requirements and tests methods); EN 980 (Graphic symbols for use in the labeling of medical devices); EN 1041 (Information supplied by the manufacturer with medical devices); and ASTM F67-06 (Standard specification for unalloyed titanium for surgical implant applications).

Clinical Performance Data

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.

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Conclusions

The design, manufacturing, function and fitting procedure of the Baha Cordelle II have not changed since it was cleared for marketing under 510(k) K992872, and testing of the Baha Cordelle II including inspectional, functional and environmental tests verify that the device meets the requirements in design specification and is substantially equivalent to previous Baha auditory osseointegrated implant system sound processors cleared by the 510(k) process.

Bench testing, as well as recently published clinical performance data, support an expanded bone-conduction hearing threshold range in the Indications for Use statement for the Baha Cordelle II so that more patients can benefit from this technology.

References:

Bosman, AJ, Snik, AFM, Mylanus, EAM, Cremers, CWRJ (2006). Fitting range of the BAHA Cordelle. International Journal of Audiology; 45: 429-437.

Killion, M (1993). The K-amp hearing aid: an attempt to present high fidelity to persons with impaired hearing. American Journal of Audiology, 2: 52-74.

Tjellstrom, A, Hakansson, B, Granstrom, G (2001). Bone-anchored hearing aids: Current status in adults and children. Otolaryngologic Clinics of North America, 34(2): 337-363.

van der Pouw, CTM, Carlsson, P, Cremers, CWRJ, Snik, AFM (1998). A new more powerful boneanchored hearing aid: First results. Scandinavian Audiology, 27: 179-182.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The graphic is surrounded by text arranged in a circular fashion, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cochlear Americas C/o Sean Bundy Regulatory Manager 400 Inverness Parkway Suite 400 Englewood, CO 80112

APR 1 0 2008

Re: K080363

Trade/Device Name: Baha Cordelle II Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing aid, bone conduction Regulatory Class: Class II Product Code: LXB Dated: February 8, 2008 Received: February 11, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Egleston, Mrs

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

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Indications for Use

080363 510(k) Number (if known): K

Device Name: Baha® Cordelle II

Indications for Use Statement:

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.

Prescription Use X (21 CFR 801 Subpart C) AND/OR

Over-The-Counter Use (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)

20 of 272

Premarket Notification - Cordelle II

Vacu

Jusion Sign-Off) ision of Ophthalmic E se and Throat Devise

30(k) Number L0820363

Regulation Number and Section

§ 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.