510(k) · Cleared
ClearedEuroline A312 Series of Behind the Ear Air Conduction Hearing Aids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starkey Laboratories, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Mar 1, 1996 as substantially equivalent to K940978 (Starkey Laboratories, Inc., 1994) after a 31-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Mar 1, 1996
- Review
- 31 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940978 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK940978 Starkey Euroline a SeriesStarkey Laboratories, Inc. · 1994
- This deviceK960494 Euroline A312 Series of Behind the Ear Air Conduction Hearing AidsStarkey Laboratories, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK963519 Euroline a-675 SerisStarkey Laboratories, Inc. · 1996
Most influential descendants
Showing 1 of 1 · See all- K963519Euroline a-675 SerisStarkey Laboratories, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940978 | Starkey Euroline a Series | Starkey Laboratories, Inc. | 1994 | — |
| 0 (this device) | K960494 | Euroline A312 Series of Behind the Ear Air Conduction Hearing Aids | Starkey Laboratories, Inc. | 1996 | — |
| +1 | K963519 | Euroline a-675 Seris | Starkey Laboratories, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940978 | Starkey Euroline a SeriesSummary page 1…ectiveness of the A-312 Series. TYPE OF DEVICE: Air Conduction Behind-the-Ear hearing aids - Substantially equivalent to the Starkey Euroline A Series BTE Hearing Aids (K940978) INTENDED USE: To assist in compensating for hearing loss by ampilifying sound as it comes near the ear . FEATURES: Adjustable… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963519 | Euroline a-675 Seris | 1996 | 0 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K963519 (Starkey Laboratories, Inc., 1996) has gone furthest, with 0 descendants of its own.
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?
To assist in compensating for hearing loss by ampilifying sound as it comes near the ear.
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/K960494 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960494: Euroline A312 Series of Behind the Ear Air Conduction Hearing Aids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960494
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026