Pocketalker Pro
510(k) K954748
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954748 | Date22 Nov 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LZI
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.3320
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Pocketalker Pro is a personal assistive listening device designed to amplify sound for individuals with mild to moderate hearing loss. Classified under the FDA’s product code LZI as an Assistive Listening Device, it enhances audio clarity for direct ear-level use, improving communication in one-on-one or small-group settings. Its primary function is to boost soft or distant speech, enabling clearer reception of verbal information in environments where ambient noise may otherwise interfere.
Supplied as a reusable, non-sterile device, the Pocketalker Pro operates on battery power and includes a headphone attachment for direct audio delivery. It features a 20dB high-frequency boost and a 25dB SPL high-volume output, as referenced in manufacturer specifications. The device is regulated under FDA 510(k) clearance (K954748) and falls under Class II medical device classification, intended for use in Ear, Nose, and Throat applications. Storage requires protection from moisture and physical damage, and it is not intended for surgical or sterile environments.
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Questions
AI-generated answers, 1 Oct 2026
What is the Pocketalker Pro designed to do?
The Pocketalker Pro is a personal assistive listening device engineered to amplify soft or distant speech, enhancing audio clarity for individuals with mild to moderate hearing loss. It is specifically tailored for direct ear-level use, making it ideal for one-on-one or small-group conversations where ambient noise could otherwise obstruct communication. The device focuses on boosting high-frequency sounds, which are often the most challenging for individuals with hearing difficulties to perceive.
Is the Pocketalker Pro reusable or single-use?
The Pocketalker Pro is a reusable device. It is not intended for sterile environments or surgical use, so it is not sterilized for single-use applications. Proper care, including protection from moisture and physical damage, is essential to maintain its functionality over repeated use.
What power source does the Pocketalker Pro use?
The Pocketalker Pro operates on battery power. This design allows for portability and ease of use in various settings, such as home, office, or public spaces. Users can easily replace or recharge the batteries as needed to ensure continuous functionality.
How should the Pocketalker Pro be stored?
The Pocketalker Pro should be stored in a dry environment, protected from moisture and physical damage. Since it is not sterile, it does not require specialized storage conditions beyond general care to prevent wear and tear. Avoid exposing it to extreme temperatures or direct sunlight, as these can affect its performance.
What are the key specifications of the Pocketalker Pro’s audio amplification?
The Pocketalker Pro features a 20dB high-frequency boost, which helps amplify sounds in the frequency range most critical for speech intelligibility. Additionally, it provides a high-volume output of 25dB SPL, ensuring that users can hear conversations clearly even in noisy environments. These specifications are designed to address the specific needs of individuals with mild to moderate hearing loss.