510(k) · Cleared
ClearedResound Real Ear Loudness Mapping (Relm) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resound Corp. · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Cleared on Mar 7, 1996 as substantially equivalent to K912669 (Resound Corp., 1991) and 2 other predicates after a 50-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Mar 7, 1996
- Review
- 50 days
- Class
- Class II
- Product code
- ETW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K872242 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872242 Type 6400 Real Ear Hearing Aid AnalyzerFrye Electronics, Inc. · 1987
- This deviceK960229 Resound Real Ear Loudness Mapping (Relm) SystemResound Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872242 | Type 6400 Real Ear Hearing Aid Analyzer | Frye Electronics, Inc. | 1987 | — |
| 0 (this device) | K960229 | Resound Real Ear Loudness Mapping (Relm) System | Resound Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 ETW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K912669 | Resound Portable Prescriptive Programming SystemSummary page 1…fect the safety or effectiveness of the currently marketed ReSound® Personal Hearing Systems. 9:33 ! ReSound® Portable Prescriptive Programming (P*) System, 510(k) No. K912669, September 16, 1991 2 Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer, 510(k) No. K872242, July 10, 1987 ’ ReSoun… | 1991 |
| * | K872242 | Type 6400 Real Ear Hearing Aid AnalyzerSummary page 1…ound® Portable Prescriptive Programming (P*) System, 510(k) No. K912669, September 16, 1991 2 Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer, 510(k) No. K872242, July 10, 1987 ’ ReSound® ReSource™, 510(k) No. K945750, March 7, 1995 * HI-Pro/Noah, 510(k) No. K942749, July 18, 1994 | 1987 |
| * | K945750 | Resound (R) Resource (TM)Summary page 1…(k) No. K912669, September 16, 1991 2 Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer, 510(k) No. K872242, July 10, 1987 ’ ReSound® ReSource™, 510(k) No. K945750, March 7, 1995 * HI-Pro/Noah, 510(k) No. K942749, July 18, 1994 | 1995 |
| † | K942749 | HI-Pro/Noah Universal Hearing Instrument | 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.
- 1 other device also cites its predicate K912669.
How does its category compare?
All ETW devicesETW Calibrator, Hearing Aid / Earphone And Analysis Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETW
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · ETW
Too few ETW 510(k)s in any year since 2007 to give a median.
Recalls per year · ETW
No recall names ETW since 2007.
Adverse event reports per year · ETW
1in 2025
MAUDE reports naming product code ETW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Similar to the Loudness Growth in Octave Bands (LGOB) Test provided with the ReSound® P3 System, this new hearing device fitting method is designed to measure loudness growth in hearing-impaired subjects in sound field, instead of with insert phones, in the unaided and aided conditions, through the use of subjective and objective measures, thus integrating both electroacoustic and psychoacoustic test capabilities.
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/K960229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960229: Resound Real Ear Loudness Mapping (Relm) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960229
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