The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive device for screening the hearing of infants between the ages of 34 weeks corrected gestational age and six months. The…
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive device for screening the hearing of infants between the ages of 34 weeks corrected gestational age and six months. The screener uses Natus’ AABR® technology. Babies should be well enough for hospital discharge, and should be asleep or in a quiet state at the time of screening. The ALGO 3i screener is simple to operate and does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants correctly. A typical screening can be completed in 15 minutes or less in any clinical environment (i.e. well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office).
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Algo 3i Newborn Hearing Screener | Listed by | Natus Medical Incorporated, United States |
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-08-28 |
| Record revised | 2026-01-09 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 5 to 90 % RH; Handling environment temperature 5 to 38 °C; Storage environment temperature -22 to 131 °F |
| Distribution end date | 2026-01-07 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.