510(k) · Cleared
ClearedSonic Innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonic Innovations, Inc. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Mar 12, 1999 as substantially equivalent to K964603 (Decibel Instruments, Inc., 1996) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Mar 12, 1999
- Review
- 81 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850123 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| −1 | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| 0 (this device) | K984518 | Sonic Innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell | Sonic Innovations, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 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? (3)
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 |
|---|---|---|---|
| * | K964603 | Articular Hearing AidsSummary page 1…ell is substantially equivalent to the SONIC innovations® CIC DSP hearing aid [510(k) not required], the Decibel Instruments Articular (inTune™) Hearing Aids [510(k) No. K964603]}, and the Hearing Components Ad-Hear Comply Disposable Earmolds [510(k)915794], i.e., it has the SAME intended use and does not… | 1996 |
| * | K915794 | AD-HearSummary page 1…10(k) not required], the Decibel Instruments Articular (inTune™) Hearing Aids [510(k) No. K964603]}, and the Hearing Components Ad-Hear Comply Disposable Earmolds [510(k)915794], i.e., it has the SAME intended use and does not raise different questions regarding safety and effectiveness. CONFIDENTIAL Pag… | 1992 |
| * | — | SONIC innovations® CIC DSP hearing aid Named without a submission number |
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 14 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K964603.
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 aid 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): Mild, Moderate.
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/K984518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984518: Sonic Innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984518
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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