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The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource II fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals.

ReSound's Digital 5000 series hearing devices are built using a custom software programmable digital signal processor. The DSP includes two analog to digital converters (ADC) at the input stage and one digital to analog converter (DAC) at the output stage. Using a personal computer (PC) connected to the hearing device via standard CS45 cable, numerous signal processing and amplification parameters may be adjusted to help compensate for impaired hearing. In addition, proprietary software used only by hearing health care professionals can instruct the output DAC to produce specific sounds. These sound stimuli, when delivered at different amplitudes and frequencies, can be used for loudness scaling measurements helpful in fitting the hearing device more precisely to the patient's residual hearing dynamic range. The LGOB test equipment is comprised of proprietary PC software and a ReSound Digital 5000 series hearing device. Similar to the Loudness Growth in Octave Bands (LGOB) test provided with the original ReSound® P3 System, this new hearing device fitting method is designed to subjectively measure loudness growth in hearingimpaired subjects using the subject's own hearing aid, instead of using insert phones. The test is to be performed only by qualified hearing healthcare professionals. When the hearing aids are disconnected from the fitting computer, they function normally.

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness.

The ReSound® Stealth CIC, a completely-in-the-canal hearing device, is an air-conduction hearing instrument, intended to amplify and transmit sound to the ear. The device is powered by a standard hearing aid battery (type 5A). The device is a completely in-the-canal one-channel device with K-Amp™ technology.

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight X 4. Severe Configuration: ✓ 1. High Frequency - Precipitously Sloping

This air-conduction behind-the-ear hearing instrument, intended to amplify sound . pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13). . The device is manufactured and delivered completely assembled to the hearing aid . dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the . ReSound® Digital 2000-BT are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™ The predicate device has the ability to retain programs in memory, and, with the use of . the optional remote control, up to three programs are accessible. The ReSound® Digital 2000-BT, however, is remote control/programmer dependent, therefore, no programs are retained in the device if the device is turned off. The ReSound® Digital 2000-DP is programmed by the hearing health care professional with up to 4 different programs per ear via Noah based ReSound ReSource™ software. . The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness

This air-conduction in-the-ear hearing instrument, intended to amplify sound pressure waves . and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe. The device is powered by a standard type 13 hearing aid battery (type 312 for the half-shell . option). The device is manufactured and delivered completely assembled to the hearing aid dispenser ● using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the ReSound® ED4 . Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System™ ED3. The ability to program digitally the fitting parameters of the hearing device is the same as in . the ReSound® Personal Hearing System™ ED3, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control.

to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe.

This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries. The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the Audallion® II Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™. The ability to program digitally the fitting parameters of the hearing device is the same as in the ReSound® BT4 Personal Hearing System™, as is the ability to change the characteristics of the sound processing and adjust the volume. The Audallion® II Hearing System has the ability to retain up to four programs in memory, whereas the predicate device has the ability to retain two.

This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.

This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13). The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the ReSound® BT4 . Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System BT. The ability to program digitally the fitting parameters of the hearing device is the same as in the ReSound® Personal Hearing System BT, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control. The ReSound® BT4 Personal Hearing System™ and the predicate device have the ability to retain two programs in memory. The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.

This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderate.

The device is powered by a standard hearing aid battery (type 10A). The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability of the hearing aid dispenser to program digitally the fitting parameters of the ReSound® CC4 hearing device is the same as in the ReSound® IC4. The ability to change the characteristics of the sound processing and to adjust the volume via an optional remote control is the same as that offered by the commercial device, the ReSound® IC4. The algorithm used by the ReSound® computerized fitting system to compute sets of fitting parameters is similar to that used for the ReSound® IC4 with adjustments made for the acoustic differences between the IC4 and the ReSound® CC4.

These air-conduction hearing instruments are intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.

These devices are powered by a standard hearing aid battery (type 13). These devices are manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the ReSound® Personal Hearing Systems EDR Encore Series are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System ED3-E. The ability to program digitally the fitting parameters of the hearing devices and the ability of the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. The EDR-E, EDR-ES, and EDR-EV are dispenser programmable, whereas the EDR-P1 programming is factory preset and may be reprogrammed at the factory only.

. This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.

. This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe. The device is powered by a standard hearing aid battery (type 13). . The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the ReSound® . Personal Hearing System EDR-7 are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System ED3-E. . The ability to program digitally the fitting parameters of the hearing device and the ability of the device to retain the program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. Seven programs are factory preset for the EDR-7 from which the dispenser may select for the fitting. The seven factory preset programs may not be modified by the dispenser via a programmer or by any other means. Modifications in the preset programming may only be accomplished at the factory.

These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe.

These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe. These devices are powered by a standard hearing aid battery (type 13). These devices are manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability to program digitally the fitting parameters of the hearing devices and the ability of . the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.