510(k) · Cleared
ClearedSonix Hearing Aid Fitting and Programming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonix Technologies, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Jan 12, 1998 as substantially equivalent to K931372 (Resound Corp., 1993) after a 90-day review. Its family tree reaches back 1 generation to 1993. 34 later devices descend from it.
- Decided
- Jan 12, 1998
- Review
- 90 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931372 (1993). 34 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK931372 Resound Portable Prescriptive Programming SystemResound Corp. · 1993
- This deviceK973880 Sonix Hearing Aid Fitting and Programming SystemSonix Technologies, Inc. · 1998
- Descendant · cites it directly · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · 2 generations on · 11 of its ownK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- Descendant · 2 generations on · 11 of its ownK103594 Ponto Pro PowerOticon Medical AB · 2011
- Descendant · 3 generations on · 10 of its ownK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- Descendant · 3 generations on · 10 of its ownK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · cites it directly33descendants
- K132278Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013 · 2 generations on11descendants
- K103594Ponto Pro PowerOticon Medical AB · 2011 · 2 generations on11descendants
- K142907Baha 5 Sound ProcessorCochlear Americas · 2015 · 3 generations on10descendants
- K132775Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931372 | Resound Portable Prescriptive Programming System | Resound Corp. | 1993 | — |
| 0 (this device) | K973880 | Sonix Hearing Aid Fitting and Programming System | Sonix Technologies, Inc. | 1998 | — |
| +1 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +2 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| +2 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| +3 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| +3 | K132775 | Ponto Plus and Ponto Plus Power | Oticon Medical AB | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K931372 | Resound Portable Prescriptive Programming SystemSummary page 1…tially equivalent to the microfit®/microtouch™ programming system by Micro-Tech {510(k) No. unknown] and the ReSound Portable Prescriptive Programming System®[510(k) No. K931372. Substantial equivalence to the predicate devices, is based on the following: « Theintended use is the same, i.e., the Sonix Hea… | 1993 |
| * | — | microfit®/microtouch™ programming system by Micro-Tech Named without a submission number |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090720 | Cochlear Baha BP100 | 2009 | 33 |
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?
The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held battery-powered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.
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/K973880 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973880: Sonix Hearing Aid Fitting and Programming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973880
Report an extraction error
Are you the manufacturer?
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