510(k) · Cleared
ClearedAuris AE, Auris TL, Auris HS, Auris AC, Auris MM, Auris Coe, Auris Cic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Hearing Instruments, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Jun 13, 1997 after a 59-day review. The FDA summary names no predicate by number.
- Decided
- Jun 13, 1997
- Review
- 59 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ESD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ESD device
- #1 K232999 Lyric4 Hearing Aidscore 8.4 · 5 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All ESD devicesESD Hearing Aid, Air-Conduction, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ESD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ESD
Too few ESD 510(k)s in any year since 2007 to give a median.
Recalls per year · ESD
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESD
53in 2025
MAUDE reports naming product code ESD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 13 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 12 |
| 2019 | 0 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Mild to severe conductive, mixed or sensoryneural hearing loss Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern. Mild to severe conductive, mixed or…
Read the full statement (125 words)
Mild to severe conductive, mixed or sensoryneural hearing loss
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern.
Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired.
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM.
Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971399: Auris AE, Auris TL, Auris HS, Auris AC, Auris MM, Auris Coe, Auris Cic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971399
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026