K Number

Device Name

WIDEXLINK IN CLEAR SERIES HEARING AIDS

Manufacturer

OFFICE RESEARCH IN CLINICAL AMPLIFICTION

Date Cleared

2011-03-31

(169 days)

Product Code

OSM

Regulation Number

874.3305

Intended Use

The CLEAR440 - PASSION (or C4-PA) hearing aid is a digital wireless air conduction hearing aid that amplifies sounds for individuals with a hearing impairment. The device is indicated for individuals with a full range of hearing loss severity (from slight (16 to 25 dB HL) to profound (90+ dB HL)) and all hearing loss configurations. The device is to be programmed by hearing healthcare professionals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing (re)habilitation.

Device Description

More Information

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Type

Center

Panel

Date Received

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Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

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Street 2

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State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

K080955

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a digital hearing aid with wireless communication capabilities and mentions a clinical study on compression, but there is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes
The device is a hearing aid, which addresses a hearing impairment, thereby providing therapeutic benefit.

Diagnostic

No
The document describes a hearing aid, which is a device that amplifies sound for individuals with hearing impairment. It does not mention any diagnostic functions, but rather focuses on sound amplification and performance in noise.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "digital air-conduction hearing aid" and mentions hardware components like a wireless radio technology (WidexLink), optional remote control (RC-DEX), and a programming module (TM-DEX). This indicates it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to amplify sounds for individuals with hearing impairment. This is a therapeutic and assistive function, not a diagnostic one.
Device Description: The device is described as a digital air-conduction hearing aid. Hearing aids are classified as medical devices, but not typically as IVDs.
Lack of Diagnostic Function: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
Performance Study: The performance study focuses on the subjective signal-to-noise ratio and speech perception, which are related to the device's function as a hearing aid, not its ability to diagnose.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This hearing aid does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OSM

Device Description

The C4-PA is a digital air-conduction hearing aid that uses WidexLink, a wireless radio technology to enable communication between a pair of hearing aids and/or between the hearing aid(s) and certain device system accessories. Accessories for WidexLink include the optional remote control (RC-DEX) and the Widex-specific programming module (TM-DEX). The RC-DEX is used by the wearer to change volume and program settings on the hearing aid(s). The TM-DEX is used during programming to fit the hearing aids. The fitting software (Compass) runs on the programming personal computer (PC). In addition, a universal programming interface - nEARcom with Bluetooth (BT)-enabled NOAHlink (non-specific to Widex), is also required to program the C4-PA hearing aid(s).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hearing healthcare professionals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing (re)habilitation.
Patients for daily use.

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

Study Aim: The study was carried out to examine the effect of IE compression on the subjective signal-to-noise ratio (SNR) when speech was presented to one side of the binaural C4-PA hearing aid wearer. The potential effect of hearing-loss symmetry was also explored in this context.

Subjects: Twelve adults (6 males) with varying degrees of bilateral sensorineural hearing loss participated in the study. Among these participants, 6 participants had asymmetrical hearing loss (≥20 dB difference between ears at two or more adjacent frequencies) and 6 had symmetrical hearing loss (0-20 dB difference between ears at any given frequency). The asymmetrical hearing-loss group included 4 males and 2 females. Four participants in the asymmetric group had sloping hearing losses (mild to moderate or severe) and two had flat losses (moderate to severe). The symmetrical group included 2 males and 4 females. Three of the symmetric group participants had mild-to-moderate sloping hearing losses and 3 had moderate-to-severe sloping hearing loss. All participants were native English speakers. Four participants in the asymmetric group and all participants in the symmetrical group had previously worn hearing aids. The asymmetrical group ranged in age from 42 to 85 years, with a mean age of 62 years. The symmetrical group ranged in age from 65 to 80 years, with a mean age of 72.5 years. All participants signed an informed consent with an explanation of the purpose of the study, benefits, and risks prior to their participation. Participants were financially compensated for their participation. The C4-PA hearing aids with occluded ear tips (qumdrop inserts) were used in the study and each participant was fit binaurally.

Procedures: Overview: ANL (Acceptable Noise Level, Nabelek) is a measure of the maximum noise level that a listener can tolerate while reportedly able to understand the speech signal. Speech stimuli were Connected Sentence Test (CST) passages. A paired comparison method was implemented to first determine the most comfortable level (MCL) for the CST passage in quiet to within 2 dB for each IE compression (on or off) and ear (left or right) condition. Speech-shaped noise from the hearing-in-noise-test (HINT) was then introduced at a level 20 dB below MCL while the CST passage was simultaneously presented at MCL. The noise level was increased by a 5-dB step size until the listener reported that s/he could no longer understand the speech. An adaptive 1-up 1-down method with a 2-dB step was used to determine the maximum noise level for which the speech was reported to still be understood. The final background noise level (BNL) for each condition was calculated as the average of last four reversals. ANL was then calculated as MCL minus BNL. The more negative the ANL, the greater the tolerance to noise, i.e., the better the performance in noise.

Audiometric data were initially obtained under headphones: masking was used as needed. Word recognition scores were obtained with the W-22 word list (1/2 lists) at the individual's MCL in quiet. Hearing aids were fit using in-situ thresholds. Hearing-aid feedback testing was completed. The gains across frequency bands of the C4-PA aids remained at default fitted settings (except for one subject's left ear for which the gain settings for soft and normal sounds were set to maximum). One master program was made available with omnidirectional microphones, noise reduction off, and TruSound stabilizer turned off. IE compression was "on" or "off" depending on the test condition and participants were blinded to the test condition.

Binaural aided MCLs were subjectively obtained for each IE compression/test ear condition for the CST passages; BNL was subsequently measured 4 times, once for each of the two IE compression conditions (on, off) and the two test ears (left, right). The speech stimuli were presented under computer control and delivered to a loudspeaker at either 90° or 270° azimuth (directed to the right or left ear). Noise was delivered to loudspeakers at 0°, 180°, and either 270° or 90° (directed to the non-test ear). This configuration allowed each ear to alternately serve as the test ear (ear with speech directed to it) with noise from the front and back as well as from the side of the non-test ear.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Preclinical/Bench Testing:

EMC and Wireless Safety: Tests were conducted on both daily use components (C4-PA hearing aid(s) and RC-DEX) and programming components (C4-PA hearing aid(s) and TM-DEX and NOAHlink) for emissions and immunity. Performance was compared against standards listed in Table 2 (EN 301 489-3 V1.4.1, IEC 60118-13:2004, EN 300 330-2 V1.3.1, FCC CFR 47 Part 15, subpart C, IEC 60601-1-2:2007, ANSI C63.19-2001). All cases passed, indicating the device system does not emit excessive radiation and is not sensitive to unrealistically low levels of electromagnetic interference.
Wireless Coexistence Testing: Five measures were conducted with various interferers (another C4-PA hearing aid, wireless hearing aids from different manufacturers, Bluetooth smartphone, airport security metal detector, etc.) to assess immunity during everyday use and programming. Interferers operated at typical frequencies and power levels. Results showed that none of the interferers degraded WidexLink and/or BT transmission, implying high immunity.

Clinical Data:

Study Type: Pilot clinical study to examine the effect of Inter-ear (IE) compression on subjective signal-to-noise ratio (SNR) when speech was presented to one side of binaural C4-PA hearing aid wearers, exploring the effect of hearing-loss symmetry.
Sample Size: 12 adults (6 males), with 6 having asymmetrical hearing loss and 6 having symmetrical hearing loss.
Key Results:
- ANL (Acceptable Noise Level):
  - No significant difference between symmetrical and asymmetrical groups in ANL with "IE on" or "IE off".
  - Significant difference between symmetrical and asymmetrical groups in "IE benefit" (ANL with “IE off” minus ANL with “IE on”).
- Asymmetrical Group:
  - Average ANL for the group was -2.8 dB with "IE on" and -2.5 dB with "IE off".
  - For the poorer ear, average ANL was -2.2 dB with “IE on” and -1.3 dB with “IE off” (not statistically significant advantage with "IE on").
  - For the better ear, average ANL was -3.3 dB with “IE on” and -3.7 dB SPL with “IE off” (not statistically significant difference).
  - No negative effect on speech perception in noise with IE-compression.
- Symmetrical Group:
  - Average "IE on" ANL was -7.00 dB and "IE off" was -3.9 dB, a difference of 3.1 dB in favor of the "IE on" condition.
  - ANL with “IE on” was significantly lower (better) than ANL with “IE off” (t(11) = -5.53, p = 0.0001, power = 1.0).
  - Potentially improved perceived signal-to-noise ratio when speech is presented to one side.
  - No negative effect on speech perception in noise with IE-compression.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Bit Error Rate (BER):
- For programming (TM-DEX to C4-PA hearing aids): better than 10^-6.
- For remote commands (RC-DEX to hearing aid(s)): better than 10^-2.
- For data update between hearing aids: better than 10^-9.
ANL (Acceptable Noise Level): Measured in dB, indicating tolerance to noise. More negative ANL is better.
- Asymmetrical Group:
  - Average ANL "IE on": -2.8 dB
  - Average ANL "IE off": -2.5 dB
- Symmetrical Group:
  - Average ANL "IE on": -7.00 dB
  - Average ANL "IE off": -3.9 dB
Power Output (EIRP):
- C4-PA hearing aid(s): 29 pW
- RC-DEX: 21 nW
- TM-DEX: 1.2 nW
- Bluetooth - NOAHlink: +4 dB re 1 mW maximum (Power class 2)
Magnetic Field Strength (at 10 m distance):
- C4-PA: -54 dBμA/m
- RC-DEX: -13 dBμA/m
- TM-DEX: -26 dBμA/m
SAR (Specific Absorption Rate): Calculated SAR value of the hearing aids of 2.9 n (analytical estimate), which is a factor of 10^7 below the SAR limit of 1.6 W/kg @ 1 g.

Predicate Device(s)

Not Found

Reference Device(s)

K080955 (mind440 hearing aid with Zen tinnitus masker)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 874.3305 Wireless air-conduction hearing aid.

(a)
Identification. A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. A wireless air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device;
(2) Performance testing must validate safety of exposure to non-ionizing radiation; and
(3) Performance data must validate wireless technology functions.
(c)
Premarket notification. The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

Summary

SUMMARY REVIEW MEMO

DATE: MARCH 31, 2011
(b)(6) (6) (6) (6) (6) FROM: , DONED/ENTB
EVALUATION OF AUTOMATIC CLASS III DESIGNATION PETITION # SUBJECT: K101699 AND C4-PA WIRELESS AIR-CONDUCTION HEARING AID

PETITIONER CONTACT:	FRANCIS KUK, PH.D.
	2300 CABOT DRIVE, SUITE 415
	LISLE, IL 60532
EMAIL:	(b)(6)
	(b)(6)
	(b)(6)

To: THE RECORD

REGULATORY INFORMATION

REGULATION NUMBER: 874.3305

FDA identifies this generic type of device within 21 CFR 874.3305 as:

A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing, that incorporates wireless technology in its programming or use.

CLASSIFICATION: II (EXEMPT FROM PREMARKET NOTIFICATION SUBJECT TO 21 CFR 874.9)

PRODUCT CODE: OSM

BACKGROUND

This premarket submission was found not substantially equivalent (NSE) on September 13, 2010 due to the lack of a predicate device with the same technological characteristics.

The petitioner is requesting an evaluation of Automatic Class III Designation for the C4-PA hearing aids with WidexLink wireless technology. The petitioner recommends that their device be reclassified into Class I or Class II. Additional hearing aid models with wireless technology will require similar bench testing as outlined in this submission.

REVIEW TEAM

Lead & Software (b)(6) ●
EMC and Wireless (b)(6) .
Audiology (b)(6) ●
Audiology - (b)(6)
Impact of electromagnetic emissions on health .
Biocompatibility -(b)(6) .

INDICATIONS FOR USE

(b)(6)

DEVICE DESCRIPTION

Figure 1. Pair of C4-PA hearing aids and RC-DEX remote control. This represents a daily use scenario.

Image /page/1/Figure/12 description: The image shows two hearing aids and a remote control. The hearing aids are behind-the-ear (BTE) style, with a small receiver that fits in the ear canal. The remote control is a small, rectangular device with a plus and minus button. The remote control is labeled as RC-Dex.

Figure 2. Arrangement of components used during programming of C4-PA hearing aid(s). The nEARcom is worn around the wearer's neck during the programming session.

Image /page/2/Picture/1 description: The image shows a personal computer with a 15.4" monitor, a nEARcom device, a TM-Dex, a BT adaptor, and a NOAHlink device. The nEARcom device is a headset-like device with two earpieces. The TM-Dex is a small, rectangular device that is attached to the nEARcom device. The BT adaptor is a small, rectangular device that is plugged into the personal computer. The NOAHlink device is a round device that is connected to the nEARcom device.

The RC-DEX is used by the wearer to change volume and program settings on the hearing aid(s). The TM-DEX is used during programming to fit the hearing aids. The fitting software (Compass) runs on the programming personal computer (PC). In addition, a universal programming interface - nEARcom with Bluetooth (BT)-enabled NOAHlink (non-specific to Widex), is also required to program the C4-PA hearing aid(s).

Technical description of WidexLink and the C4-PA device system

WidexLink is a low power, short-range, proprietary radio which enables communication between the C4-PA hearing aid(s) and certain peripheral units (RC-DEX and TM-DEX). Table 1 contains specifications for the wireless technology, including WidexLink, of appropriate components of the device system. WidexLink is used in two configurations/modes:

1. Programming mode In this mode, the C4-PA hearing aid(s) are programmed bv the fitting clinician. Programming is conducted wirelessly (without cables) through the TM-DEX, which is used in combination with the NOAHlink/ nEARcom (see Figure 2 above). During programming, the TM-DEX provides a two-way link for exchange of data between the PC and the hearing aids (semi-duplex) via NOAHlink. The transmission of information through the various programming components occurs as follows:
- . Compass fitting software - The source code for the applied programming unit is compiled into the fitting software called Compass.
- NOAHlink driver NOAHlink is a wireless converter between the PC interface . and various electrical communication devices. To use NOAHlink, the user logs in via a basic NOAHlink driver object within the PC. Only one user is allowed at any one time. Once logged in, the user is assigned a randomized

handle (8 bits) that allows access the desired protocol (Inter-Integrated Circuit [12C] for the C4-PA hearing aid). Login to a protocol object automatically makes the NOAHlink driver download a binary protocol for the NOAHlink hardware - this protocol is used to manage the NOAHlink hardware during communication.

Bluetooth (BT) connection Data from the Compass fitting software are sent . to NOAHlink via the NOAHlink driver using a wireless Bluetooth (BT) connection operating in the 2.4 GHz frequency band. NOAHlink uses a Class II Bluetooth which includes only one Bluetooth profile (SPP) for login. Once the NOAHlink driver is logged in via the PC's BT module, the user will only be allowed to discover, but not log into NOAHlink from another BT module in the environment. Specifications for the BT connectivity used in NOAHlink follow:
- o BT version 2.0
- o BT Profile SPP (Serial Port Profile)
- o Fixed passkey (b)(4) (due to Windows XP BT Stack that cannot run in un-secure mode)
NOAHlink The wireless converter (NOAHlink) receives/transmits data ● from/to the PC (via BT). NOAHlink transmits/receives data from the C4-PA hearing aid(s) via the I2C protocol. For communication with the C4-PA hearing aid(s), data are wirelessly sent via the nEARcom/ TM-DEX wireless programming/ fitting module.
. nEARcom - The nEARcom is the physical housing that houses and allows the choice of the desired wireless fitting modules. One of five fitting modules can be inserted in the nEARcom. TM-DEX is the name of the fitting module for the C4-PA hearing aid(s). Once a fitting module is enabled, nEARcom becomes a passive element in communication.
TM-DEX Depending on the I2C address and destination Media Access . Control (MAC) address, the TM-DEX routes commands from the fitting software to the relevant hardware. Some commands target the TM-DEX module while others are routed across the wireless interface via WidexLink to the C4-PA hearing aid(s). A carrier frequency at 10.6 MHz is used for the WidexLink digital transmission between the TM-DEX and the hearing aid(s) (described further below and in Table 1).
C4-PA hearing aid the C4-PA hearing aid(s) receive programming/fitting . data from the TM-DEX wirelessly one hearing aid at a time. To communicate with a hearing aid, the TM-DEX needs to know the MAC address of or be recognized by the hearing aid. The C4-PA hearing aid is powered by a standard 1.4 V Zn-Air hearing aid battery.
1. Daily use mode This is the mode in which the wearers use the C4-PA hearing aid(s), in either a monaural or binaural fashion. Figure 1 shows the components of the daily use configuration. When a pair of C4-PA hearing aids is used binaurally, data is transmitted between the hearing aids (referred to as inter-ear communication) in a semi-duplex manner. The hearing aids update parameter settings 20 times per second automatically and continuously. When the C4-PA hearing aid is used in a monaural manner, no automatic update of hearing aid

settings will be available. In addition, the wearer can choose to use the external remote control (RC-DEX) to make volume and program changes on the hearing aid either monaurally or binaurally. RC-DEX transmits data to the hearing aid(s) in a one-way (or simplex) manner. A carrier frequency at 10.6 MHz is used for the WidexLink digital transmission between the RC-DEX and the hearing aid(s)

Range - Figure 3 (below) shows the range of wireless communication among the C4-PA hearing aids and other components of the device system. The range is within 30 cm between the pair of hearing aids. less than one meter between the hearing aid(s) and the RC-DEX, and less than 30 cm between the TM-DEX and the hearing aid(s). All communication inside the large blue circle is accomplished wirelessly through the shortrange WidexLink radio. The RC-DEX and C4-PA hearing aid(s) lie completely inside this circle, as they contain only the WidexLink wireless radio. The BT connection between the personal computer and NOAHlink used during hearing-aid fitting has a transmission range of less than 10 meters (Power Class II).

Figure 3: Relationship and range of transmission of the various WidexLink and programming components.

Image /page/4/Figure/3 description: The image shows a diagram of a communication network between several devices. The network includes RCDEX, Clear440, TMDEX, nEARcom/Noahlink programmer, and a PC. The devices are connected via WidexLink communication and Bluetooth, with distances of less than 1 meter, less than 30 cm, and less than 10 meters indicated between the devices.

WidexLink specifications - WidexLink is the proprietary radio used in the C4-PA hearing aid(s), RC-DEX, and TM-DEX. WidexLink is an inductive short-range device (SRD) using an inductive ferrite coil antenna and Frequency Shift Keying (FSK)

modulation with a carrier frequency at 10.6 MHz and a bandwidth of 660 kHz (-15 dB). The radio chip is identical in all units (C4-PA, TM-DEX, RC-DEX) although the exact configuration is component specific. The transmitter produces a modulated magnetic field from the alternating current that passes through the antenna coils, and the RF receiver picks up the modulated magnetic field and converts this to a voltage which is fed to the radio receiver. WidexLink is a single channel digital radio with a raw channel capacity of 212 kbit/s. The hearing aids and the TM-DEX use a semi-duplex data flow (meaning data flow in both directions, but not simultaneously) while the RC-DEX uses a simplex or one-way data flow. The RC-DEX is available for C4-PA users to control the program and volume settings on the hearing aids, and the TM-DEX is only available to the hearing aid dispenser/ professional for programming the C4-PA hearing aid(s). All components containing WidexLink (C4-PA, TM-DEX, RC-DEX) use a Random Access protocol with no collision avoidance when transmitting data. All configurations of radio modules are set by either Widex or by the Compass fitting software during fitting; the user cannot configure the radio.

NOAHlink BT specifications - NOAHlink communicates with the programming PC through a Bluetooth radio (BT version 2.0; Serial Port Profile (SPP); fixed Pass Key for security) which uses a 2.4 GHz carrier with 79 channels and a bandwidth of 1 MHz.

Technical details of the WidexLink and BT radios used in the C4-PA device system are summarized in Table 1:

Table 1. Technical specifications of radios in the C4-PA device system. *Bluetooth specification v2.0 + EDR published by the Bluetooth Special Interest Group (SIG); Bluetooth Identifier: B01837; Reference number of Qualified Product Notice (QPN):

NOAHlinkV1.2_412832_QPN_E1. **EIRP: Equivalent isotropically radiated power. ***FHSS: Frequency-hopping spread spectrum. GFSK: Gaussian Frequency-Shift Keying; π/4 DPSK: Differential Phase-shift keying with 4 constellation points rotated 45°; 8 DPSK: Differential Phase-shift keying with 8 constellation points.

| | C4-PA hearing
aid(s) | RC-DEX | TM-DEX | Bluetooth* -
NOAHlink |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------|
| Antenna type | Inductive
antenna | Inductive
antenna | Inductive
antenna | Embedded
ceramic
antenna |
| Antenna
dimensions | Ø1.8 mm,
L - 4.85 mm | Ø8 mm,
L - 20 mm | Ø6 mm,
L – 8 mm | NA |
| Modulation | FSK | FSK | FSK | FHSS/GFSK,
π/4 DPSK, 8
DPSK*** |
| Magnetic Field
Strength (at 10
m distance) | -54 dBμA/m | -13 dBμA/m | -26 dBμA/m | NA |
| Output power
(EIRP**) | 29 pW | 21 nW | 1.2 nW | +4 dB re 1 mW
maximum
(Power class
2) |
| Range |