STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS

K964244 · Starkey Laboratories, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964244
• Device Name: STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
• Applicant: Starkey Laboratories, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear.

Device Story

Custom-fit air conduction hearing aids (ITE, ITC, CIC); amplify sound pressure waves for hearing loss compensation. Operated by hearing health professionals; programmed via Pro-Connect, Hi-Pro, Rastronics pr3000, or PFS 6000 systems using PFS software. Features include adjustable volume, color coding, and 6 programmable options (Low/High cut, Gain, Compression ratio, Threshold knee, Output limiting/Loudness Boost). Powered by standard hearing aid batteries. Non-volatile memory stores settings. Output adjustments based on patient-specific frequency response needs.

Clinical Evidence

Bench testing only; compliance with ANSI S3.22-1987 standards for technical specifications.

Technological Characteristics

Air conduction hearing aids; ITE, ITC, CIC form factors. Class D output circuitry. Programmable features: Low cut, High cut, Gain, Compression ratio, Threshold knee, Output limiting/Loudness Boost. Powered by standard batteries. Technical specs comply with ANSI S3.22-1987. Tolerances: ± 4 dB for SSPL/slope, +6/-4 dB for gain.

Indications for Use

Indicated for patients with hearing loss requiring air conduction amplification; available as ITE, ITC, or CIC form factors.

Regulatory Classification

Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

Predicate Devices

• Starkey CE-9 Resolution programmable hearing aid (K933989)

Reference Devices

• Pro-Connect (K932269)

Submission Summary (Full Text)

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K964244

NOV 27 1996

# SAFETY AND EFFECTIVENESS SUMMARY - Starkey Custom Sequel Programmable, K Amp Programmable

| NAME OF DEVICE: | Starkey Custom Sequel Programmable and K Amp programmable air conduction hearing aids. |
| --- | --- |
| TYPE OF DEVICE: | Custom fit air conduction hearing aids available as ITE, ITC, or CIC -- Substantially equivalent to the Starkey CE-9 Resolution programmable hearing aid, (K933989) |
| INTENDED USE: | To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear. |
| FEATURES: | Adjustable hearing aid volume control, color coding for left and right instruments, 6 programmable options: Low cut, High cut, Gain control, Compression ratio, Threshold knee, and Output limiting for Sequel, or Loudness Boost for K Amp. |
| ASSEMBLY: | Assembled from standard components that are widely used in hearing aid devices throughout the industry. |
| TECHNICAL CHARACTERISTICS: | Technical specifications comply with ANSI S3.22-1987 |
| FIT: | Frequency response varying based on the needs of the patient. Tolerances are maintained to a ± 4 dB range for SSPL and slope, with +6 dB, -4 dB for gain. |
| CONTROLS: | Volume controls, similar to those used on other hearing aid devices. Switches may be incorporated as options require. Any switches are similar to those used in other hearing aid devices. |
| POWER: | Standard hearing aid batteries. |

10/16/96

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# SUMMARY—STARKEY Custom Sequel Programmable and K Amp Programmable SUBSTANTIAL EQUIVALENCE

The Starkey Custom Sequel Programmable and K-Amp Programmable are air conduction hearing aids that are designed to be all-in-the-ear hearing aids. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.

The Starkey Custom Sequel Programmable and K-Amp Programmable aids are substantially equivalent to the Starkey CE-9 Resolution(K933989). The Starkey Custom Sequel Programmable and K-Amp Programmable are available as ITE, ITC, and CIC hearing aids. They are programmed by using the Pro-Connect (K932269) or Hi-Pro systems with the PFS software. The may also be programmed with the Rastronics pr3000 with the PFS software, or the PFS 6000.

## CE 9 RESOLUTION

- Available as ITE
- 6 Programmable Features
- Programmed with Trilogy Desktop or Pro-Connect
- Non Volatile Memory
- Full range programmability from 105dB SSPL to 125dB SSPL, 30dB gain to 60dB gain
- Class D output instrument with compression available
- Memory holds two responses which can be switched by user

## Custom Sequel, K Amp Programmable

- Available as ITE, ITC, CIC
- 6 Programmable Features
- Programmed with Pro-Connect or Hi-Pro systems and PFS software
- Non Volatile Memory
- Full range programmability from 100dB SSPL to 117dB SSPL, 20dB gain to 50dB gain
- Totally programmable class D compression instrument
- Programmable with pr3000 with PFS software or PFS 6000

10/16/96