510(k) · Cleared
ClearedAir Conduction Haearing Aids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beltone Electronics Corp. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Aug 15, 1997 as substantially equivalent to K951587 (Beltone Electronics Corp., 1995) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 15, 1997
- Review
- 87 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K940102 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK940102 Beltone Opera/Opera MHP/Opera MaxBeltone Electronics Corp. · 1994
- This deviceK971852 Air Conduction Haearing AidsBeltone Electronics Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940102 | Beltone Opera/Opera MHP/Opera Max | Beltone Electronics Corp. | 1994 | — |
| 0 (this device) | K971852 | Air Conduction Haearing Aids | Beltone Electronics Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951587 | Beltone Petite Plus Beltone Petite Plus Clearvioce KSummary page 1…FFECTIVENESS INFORMATION NAME OF DEVICE: TYPE OF DEVICE: INTENDED USE: FEATURES: ASSEMBLY: TECHNICAL CHARACTERISTICS: FIT: CONTROLS: POWER: Beltone Petite Plus K951587 AUG 15 1997 Beltone Optima 2000 K9542213 Beltone Opera K940102 Beltone Invisa K940098 The devices are ITE, ITC, and CIC air co… | 1995 |
| Kept off the family tree | K954213 | FDA’s K954213 is Ath Full Profile Acetabular Cup System Our OCR of the scanned summary read K954213, FDA’s number for Ath Full Profile Acetabular Cup System (Kinamed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Beltone Optima 2000”. Kept off the family tree. | 1995 |
| * | K940102 | Beltone Opera/Opera MHP/Opera MaxSummary page 1…NDED USE: FEATURES: ASSEMBLY: TECHNICAL CHARACTERISTICS: FIT: CONTROLS: POWER: Beltone Petite Plus K951587 AUG 15 1997 Beltone Optima 2000 K9542213 Beltone Opera K940102 Beltone Invisa K940098 The devices are ITE, ITC, and CIC air conduction hearing aids previously given marketing approval by the… | 1994 |
| * | K940098 | Beltone InvisaSummary page 1…SEMBLY: TECHNICAL CHARACTERISTICS: FIT: CONTROLS: POWER: Beltone Petite Plus K951587 AUG 15 1997 Beltone Optima 2000 K9542213 Beltone Opera K940102 Beltone Invisa K940098 The devices are ITE, ITC, and CIC air conduction hearing aids previously given marketing approval by the FDA. Beltone will be ad… | 1994 |
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?
- 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?
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies):
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/K971852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971852: Air Conduction Haearing Aids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971852
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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