510(k) · Cleared
ClearedResound BT4 Personal Hearing System W/Remote Control Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resound Corp. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Nov 27, 1996 as substantially equivalent to K912665 (Resound Corp., 1991) after a 14-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Nov 27, 1996
- Review
- 14 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912665 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912665 System BT W/Remote Control Option Hearing AidResound Corp. · 1991
- This deviceK964557 Resound BT4 Personal Hearing System W/Remote Control OptionResound Corp. · 1996
- Descendant · cites it directly · 0 of its ownK974257 Resound Digital 2000-BT W/Digital 2000-DF (Digital Programmer)Resound Corp. · 1997
- Descendant · cites it directly · 0 of its ownK970215 Audallion II Hearing SystemResound Corp. · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912665 | System BT W/Remote Control Option Hearing Aid | Resound Corp. | 1991 | — |
| 0 (this device) | K964557 | Resound BT4 Personal Hearing System W/Remote Control Option | Resound Corp. | 1996 | — |
| +1 | K974257 | Resound Digital 2000-BT W/Digital 2000-DF (Digital Programmer) | Resound Corp. | 1997 | — |
| +1 | K970215 | Audallion II Hearing System | Resound Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K912665 | System BT W/Remote Control Option Hearing AidSummary page 1…Substantial equivalence for the ReSound® BT4 Personal Hearing System™ to the predicate device, the ReSound® Personal Hearing System BT (marketed as the BT2), 510(k) No. K912665/A, July 24, 1991, is based on the following: e This air-conduction behind-the-ear hearing instrument, intended to amplify sound… | 1991 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K974257 (Resound Corp., 1997) 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?
This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.
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/K964557 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964557: Resound BT4 Personal Hearing System W/Remote Control Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964557
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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