510(k) · Cleared
ClearedMiracle Ear and Audiotone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miracle-Ear, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Dec 22, 1995 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 22, 1995
- Review
- 53 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK954941 Miracle Ear and AudiotoneMiracle-Ear, Inc. · 1995
- Descendant · cites it directly · 3 of its ownK960804 Miracle Ear & Audiotone Model Ite/Itc/CicMiracle-Ear, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK964530 Dahlberg Hearing Aid with Multi-Channel Compression CircuitMiracle-Ear, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK972345 Dahlberg/Miracle-EarMiracle-Ear, Inc. · 1997
- Descendant · 3 generations on · 0 of its ownK970262 Multi-Channel Compression Bte (SD)Miracle-Ear, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK964794 Dahlberg K-Amp BteMiracle-Ear, Inc. · 1996
Most influential descendants
Showing 5 of 5 · See all- K960804Miracle Ear & Audiotone Model Ite/Itc/CicMiracle-Ear, Inc. · 1996 · cites it directly3descendants
- K964530Dahlberg Hearing Aid with Multi-Channel Compression CircuitMiracle-Ear, Inc. · 1996 · 2 generations on1descendant
- K972345Dahlberg/Miracle-EarMiracle-Ear, Inc. · 1997 · 2 generations on0descendants
- K970262Multi-Channel Compression Bte (SD)Miracle-Ear, Inc. · 1997 · 3 generations on0descendants
- K964794Dahlberg K-Amp BteMiracle-Ear, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954941 | Miracle Ear and Audiotone | Miracle-Ear, Inc. | 1995 | — |
| +1 | K960804 | Miracle Ear & Audiotone Model Ite/Itc/Cic | Miracle-Ear, Inc. | 1996 | — |
| +2 | K964530 | Dahlberg Hearing Aid with Multi-Channel Compression Circuit | Miracle-Ear, Inc. | 1996 | — |
| +2 | K972345 | Dahlberg/Miracle-Ear | Miracle-Ear, Inc. | 1997 | — |
| +3 | K970262 | Multi-Channel Compression Bte (SD) | Miracle-Ear, Inc. | 1997 | — |
| +1 | K964794 | Dahlberg K-Amp Bte | Miracle-Ear, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K960804 (Miracle-Ear, Inc., 1996) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K954941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954941: Miracle Ear and Audiotone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954941
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026