510(k) · Cleared
ClearedMulti-Channel Compression Bte (SD)
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 Mar 31, 1997 as substantially equivalent to K964530 (Miracle-Ear, Inc., 1996) after a 67-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 31, 1997
- Review
- 67 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954941 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK954941 Miracle Ear and AudiotoneMiracle-Ear, Inc. · 1995
- 2 generations backK960804 Miracle Ear & Audiotone Model Ite/Itc/CicMiracle-Ear, Inc. · 1996
- 1 generation backK964530 Dahlberg Hearing Aid with Multi-Channel Compression CircuitMiracle-Ear, Inc. · 1996
- This deviceK970262 Multi-Channel Compression Bte (SD)Miracle-Ear, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954941 | Miracle Ear and Audiotone | Miracle-Ear, Inc. | 1995 | — |
| −2 | 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 | — |
| 0 (this device) | K970262 | Multi-Channel Compression Bte (SD) | Miracle-Ear, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K964530 | Dahlberg Hearing Aid with Multi-Channel Compression CircuitSummary page 1…ass I. To amplify and transmit sound to the ear. Dahlberg multi-channel compression BTE hearing aids which were cleared for distribution under document control number K964530. 2110592 The hearing aid shells will be manufactured from materials that are commonly used in the industry. The hearing aid wi… | 1996 |
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.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 3 ancestors has a 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?
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/K970262 · printed Nov 3, 2026
Cite this page
510(k) Report. “K970262: Multi-Channel Compression Bte (SD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970262
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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