510(k) · Cleared
ClearedMiracle Ear & Audiotone Model Ite/Itc/Cic
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 Apr 5, 1996 as substantially equivalent to K954941 (Miracle-Ear, Inc., 1995) after a 37-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Apr 5, 1996
- Review
- 37 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954941 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954941 Miracle Ear and AudiotoneMiracle-Ear, Inc. · 1995
- This deviceK960804 Miracle Ear & Audiotone Model Ite/Itc/CicMiracle-Ear, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK964530 Dahlberg Hearing Aid with Multi-Channel Compression CircuitMiracle-Ear, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK972345 Dahlberg/Miracle-EarMiracle-Ear, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK970262 Multi-Channel Compression Bte (SD)Miracle-Ear, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K964530Dahlberg Hearing Aid with Multi-Channel Compression CircuitMiracle-Ear, Inc. · 1996 · cites it directly1descendant
- K972345Dahlberg/Miracle-EarMiracle-Ear, Inc. · 1997 · cites it directly0descendants
- K970262Multi-Channel Compression Bte (SD)Miracle-Ear, Inc. · 1997 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954941 | Miracle Ear and Audiotone | Miracle-Ear, Inc. | 1995 | — |
| 0 (this device) | K960804 | Miracle Ear & Audiotone Model Ite/Itc/Cic | Miracle-Ear, Inc. | 1996 | — |
| +1 | K964530 | Dahlberg Hearing Aid with Multi-Channel Compression Circuit | Miracle-Ear, Inc. | 1996 | — |
| +1 | K972345 | Dahlberg/Miracle-Ear | Miracle-Ear, Inc. | 1997 | — |
| +2 | K970262 | Multi-Channel Compression Bte (SD) | Miracle-Ear, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 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 |
|---|---|---|---|
| * | K954941 | Miracle Ear and AudiotoneSummary page 1…on Hearing Aid (77ESD), Class 1. To amplify and transmit sound to the ear. Dahlberg K-AMP hearing aids which were cleared for distribution under document control number K954941. 2110592 The hearing aid shells will be manufactured from materials that are commonly used in the industry. The hearing aid wi… | 1995 |
What descends from it? (3)
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?
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 amplify and transmit sound to 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/K960804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960804: Miracle Ear & Audiotone Model Ite/Itc/Cic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960804
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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