510(k) · Cleared
ClearedDigital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resound Corp. · EWO Audiometer
Cleared on Mar 19, 1999 as substantially equivalent to K912669 (Resound Corp., 1991) after an 87-day review. Its family tree reaches back 1 generation to 1991. 34 later devices descend from it.
- Decided
- Mar 19, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912669 (1991). 34 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK912669 Resound Portable Prescriptive Programming SystemResound Corp. · 1991
- This deviceK984547 Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing AidsResound Corp. · 1999
- 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 | K912669 | Resound Portable Prescriptive Programming System | Resound Corp. | 1991 | — |
| 0 (this device) | K984547 | Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids | Resound Corp. | 1999 | — |
| +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 EWO? 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 EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K912669 | Resound Portable Prescriptive Programming SystemSummary page 2…ther currently marketed audiometric diagnostic testing equipment, and is almost identical to that marketed as the ReSound® Portable Prescriptive Programming (P3) System (K912669). ReSound’s Digital 5000 series hearing devices are built using a custom software programmable digital signal processor. The DSP… | 1991 |
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 EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, 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 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource 11 fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals. The purpose of the ReSound LGOB test is to evaluate a patient’s suprathreshold hearing at specific…
Read the full statement (300 words)
The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource 11 fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals.
The purpose of the ReSound LGOB test is to evaluate a patient’s suprathreshold hearing at specific frequencies. This is the range of hearing above a person’s threshold level but below their uncomfortable loudness level. The results of this test are used by the ReSource software to calculate hearing instrument fittings that are better tailored to the patient’s residual dynamic range of hearing. The LGOB test procedure requires the patient to evaluate narrow bands of noise signals generated directly the Digital-to-Analog converter within the hearing device. The patient indicates if the noise signal is Too Loud, Very Loud, Loud, Comfortable, Soft, Very Soft or Inaudible by entering their response with the hand held Personal Selector, which is the identical recording device used with the original P® system from ReSound.
The new LGOB application uses the patient’s own digital hearing device or a stock “Digital Master” device to produce the sound stimulus directly from the Digital to Analog converter (DAC) within the hearing aid’s Digital Signal Processor. No insert earphones are required. Either BTE or Custom In-The-Ear devices can be used to perform the LGOB loudness scaling measurements. The test protocol is initiated and controlled by connecting a Digital hearing device to a personal computer and using proprietary fitting software (ReSource II). When the fitting computer is disconnected, the hearing instrument functions normally.
Results from the test are used to provide fitting recommendations and initial device amplification parameter settings for the Digital 5000 and other programmable ReSound hearing devices.
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/K984547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984547: Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984547
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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