Clinical UM Guideline

Percutaneous electrical nerve field stimulation (PENFS) has been evaluated for treating various conditions including but not limited to abdominal pain‐related disorders of gut-brain interaction and for reducing opioid withdrawal symptoms. PENFS is administered through a nonimplanted device that is worn behind the ear to target central pain pathways involved in pain amplification. PENFS is also referred to as auricular PENFS and percutaneous auricular neurostimulation.

Medically Necessary:

An initial course of PENFS therapy is considered medically necessary in individuals who meet ALL (A, B, and C) of the following criteria:

1. 8-21 years of age; and
2. Have functional abdominal pain associated with either of the following (1 or 2):
   1. Irritable bowel syndrome (IBS); or
   2. Functional dyspepsia (FD);
      and
3. Continue to have unrelenting, refractory pain which interferes with functioning despite standard therapy.

Note: For additional information regarding an initial course of PENFS therapy, see the Discussion/General Information section below.

Not Medically Necessary:

A course of PENFS therapy is considered not medically necessary for all other indications, including when the medically necessary criteria above are not met.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure code listed above when criteria are not met or for all other diagnoses not listed; or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary.

When services are also Not Medically Necessary:
For the codes listed below for all indications, or when the code describes a procedure or device indicated in the Clinical Indications section as not medically necessary.

Summary

A percutaneous electrical nerve field stimulator device is comprised of a disposable battery-operated stimulator that is worn behind the ear and connected to stimulation needles that are positioned along branches of the occipital and cranial nerves. Unlike other electrical stimulation methods that focus on specific nerves, the percutaneous electrical nerve field stimulator targets a broader area, including multiple nerves and brain regions involved in processing pain.

Abdominal pain-related disorders of gut-brain interaction (AP-DGBI), such as irritable bowel syndrome (IBS), functional abdominal pain-not otherwise specified (FAP-NOS), abdominal migraine (AM), and functional dyspepsia (FD), are prevalent among children and adolescents worldwide. These conditions often lead to significant quality-of-life (QOL) challenges, including school absenteeism, psychological issues like anxiety and depression, and can persist in adulthood. The most common cause of chronic abdominal pain in this demographic, AP-DGBIs, involves complex interactions between the enteric and central nervous systems. Although various treatments, including dietary, pharmacological, and behavioral therapies, have been explored, the evidence for their effectiveness is limited, making it challenging to determine the most effective treatment strategies.

Recent studies have evaluated the use of PENFS for treating functional abdominal pain (FAP) in young patients. However, the studies have noted limitations such as the absence of long-term efficacy data and limited changes in bowel habits. Despite these constraints, secondary analyses affirm the potential of PENFS in improving symptoms of AP-DGBI. Notably, the European and North American Societies for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN and NASPGHAN) have acknowledged PENFS as a viable treatment option for children and adolescents with FAP associated with IBS that is refractory to standard therapy, though they emphasize this recommendation as conditional and suggest that more research is needed to fully validate the treatment's efficacy. This recommendation was based on a systematic review and synthesis of pharmacological and non-pharmacological treatments, which highlighted significant evidence gaps in treating these disorders and demonstrated that the pain intensity reduction using PENFS was among the highest across all studied treatment options.

The evidence demonstrating the effectiveness of PENFS for the management of AP-IBS is based on a few relatively small studies with short-term outcomes. However, given the chronic nature of AP-IBS which can persist from early childhood into adulthood, its impact on QOL and associated psychological issues, and the lack of effective treatment options for some children, PENFS may be considered a reasonable option for the subset of children age 11 to 18 years with refractory AP-IBS who have failed to achieve sustained relief with other standard treatment options. Limited peer-reviewed evidence has demonstrated that PENFS modulates central pain pathways via stimulation of the auricular branches of cranial nerves following 4-weeks of treatment, with sustained efficacy.

Discussion

Abdominal Pain Related to Disorders of Gut-brain Interaction (AP-DGBI)

Disorders of gut-brain interaction (DGBIs) are the main cause of chronic abdominal pain (AP) in children and adolescents, arising from the interplay between the enteric and central nervous systems. These disorders can lead to atypical pain, such as discomfort following rectal distension in IBS, impaired gastric relaxation response to meals, nausea, and increased pain sensitivity (visceral hyperalgesia) due to central regulation issues affecting the pain threshold.

AP-DGBIs significantly impact QOL due to chronic pain and associated psychological issues, such as depression and anxiety. According to the Rome IV criteria (Drossman, 2016), these disorders are classified into four categories: IBS, FAP-NOS, functional dyspepsia (FD), and abdominal migraine. IBS and FAP, in particular, have substantial clinical overlap and may share a common etiopathogenetic pathway, possibly representing different expressions of the same disorder, with pain manifestations being similar and differentiation primarily based on defecation patterns (Groen, 2025; Hyams, 2016).

In clinical and research contexts, the term "AP-DGBI" is replacing older terms like "functional gastrointestinal disorders" and "functional abdominal pain disorders." This shift emphasizes the two-way interaction between the enteric and central nervous systems, recognizing the role of both gastrointestinal and psychosocial factors in contributing to symptoms.

Management approaches for AP-DGBI focus on reducing chronic pain and restoring function, utilizing a range of strategies such as pharmacological therapies, dietary changes, gut-brain psychotherapies, probiotics, and PENFS (Groen, 2025).

PENFS to Treat Functional AP-DGBI

The PENFS device is a single-use, battery-operated system that delivers low-frequency electrical impulses to the cranial (V, VII, IX, X) and occipital nerves in the ear to help modulate pain-processing brain regions. It includes a stimulator placed behind the ear connected to a four-lead electrode array with thin needle electrodes positioned at specific ear points (preauricular, lobule, and superior crus) where cranial nerve peripheral branches are located just beneath the skin. A transilluminator aids clinicians in identifying neurovascular structures for precise electrode placement, and the device is worn for 120 hours per week before being disposed of.

PENFS has been evaluated in a single double-blind sham-controlled RCT (Kovacic, 2017). The study enrolled 115 adolescents aged 11 to 18 years with chronic AP who met ROME III criteria for a functional abdominal disorder (IBS, functional dyspepsia, abdominal migraine, FAP or FAP syndrome). In addition, individuals needed to have an average AP score of 3 or higher (on a 10-point scale) and a minimum of 2 days per week of pain. Participants received either active (n=60) or sham (n=55) stimulation with the Neuro-Stim device (now known as the IB-Stim device, Innovative Health Solutions). The device was placed behind the ear each week for 4 weeks during clinic visits, and individuals were instructed to keep the device on for 5 days and then remove it for the last 2 days of the week. The sham devices were manufactured identically to the active devices, but without electrical charge. While the investigators claimed that both active stimulation and sham were below sensation threshold, they noted that some individuals could potentially experience an auricular sensation after device placement. At the end of week 3, 75% of individuals in the PENFS group thought they had the active device and 46% of individuals in the sham group thought they had the active device. Participants completed Pain Frequency-Severity-Duration (PFSD) questionnaires (maximum possible score=70) at visits after the first 3 weeks of treatment and at a follow-up visit at 8 to 12 weeks. The primary outcome was change in AP scores (change in worst pain intensity and a composite PFSD score). Global symptom improvement was assessed as a secondary endpoint using the Symptom Response Scale (SRS). Individuals were followed for a median of 9.2 weeks after the last week of treatment.

A total of 104 of the 115 participants (90%) were included in the primary analysis: 57 in the active PENFS group, and 47 in the sham group. One participant in the PENFS group and 7 in the sham group discontinued treatment. Between baseline and week 3, the worst pain score showed statistically significantly greater improvement in the PENFS group compared with the sham group (difference between groups 2.15 points, p<0.0001). However, there was no significant difference between the PENFS group and sham group in the proportion of participants who had an improvement of 30% of more in worst pain (p=0.47) or usual pain (p=0.11) from baseline to extended follow-up. The median PFSD composite scores decreased significantly more in the PENFS compared to sham treatment group (difference between groups, 11.48 points, p<0.0001) at week 3. At extended follow-up, both the median worst pain score (p=0.019) and the composite PFSD score (p=0.018) improved significantly more in the PENFS group compared with the sham treatment group. SRS scores reflected improvements in the PENFS group at 3 weeks versus the sham group (p=0.0003), no significant difference between groups was observed at the extended follow-up. The authors noted that the study did not assess changes in bowel habits, considered the most bothersome IBS symptom, and only focused on pain reduction. Reported side effects were similar in the 2 groups and there were no serious adverse events (SAEs).

Several secondary analyses of the Kovacic (2017) RCT have been published. Krasaelap and colleagues (2020) reported on 50 participants with IBS (27 from the PENFS group and 23 in the sham group). They found that significantly more individuals in the active treatment group had at least a 30% or more reduction in worst AP than individuals in the sham group at 3 weeks (59% vs. 26%, p=0.024). Kovacic (2020) examined the association between treatment efficacy and a pre-treatment physiological measure known as vagal efficiency (VE), which was defined as the change in heart rate per unit change in respiratory sinus arrhythmia. The authors found a statistically significant association between low VE and pain reduction in the treatment group and no significant associations in the sham or high-VE groups.

Santucci (2022) published data on 20 individuals aged 11-19 years with FAP disorders who were treated with PENFS for 4 weeks. The primary aim of the study was the impact of PENFS on AP and nausea. After treatment, resting VAS ratings for pain unpleasantness were significantly lower (p=0.03). The VAS ratings for nausea did not change significantly after treatment (p=0.10) and pain intensity was not significantly reduced (p=0.06). This study lacks a control or comparison group.

In 2023, Chogle and colleagues reported on data from an open-label registry of children aged 8 to 18 years undergoing PENFS for AP-DGBI. Up to 12 weeks of data were available per participant. Each week, trained professionals placed the PENFS device on participants, who wore them for 5 days, at which point the family removed the device. A total of 371 individuals were included in the database, and 292 had sufficient data available for the analysis. Compared with child-reported median API scores at baseline (2.68, n=288), scores were significantly improved at 3 weeks (1.99, n=209) and at 3 and 6 months (p<0.001 for each comparison). Sample size was only 75 at 3 months and 60 at 6 months. Parent-reported API scores were similar to the child reports. This study lacked a comparison group and had inconsistent follow-up.

In another study, Chogle and colleagues (2024) explored the efficacy of PENFS as a standard treatment for pediatric AP-DGBI through a multicenter, prospective open-label registry. The study was conducted across seven tertiary care gastroenterology clinics and included children aged 8 to 18 years, with subtypes classified by Rome IV criteria. Participants and their parents completed questionnaires on AP, nausea severity, and functional disability before, during, and up to one year after therapy.

A total of 292 children participated, predominantly female, with a median age of 16.3 years. Most participants met criteria for functional dyspepsia and had failed multiple pharmacologic therapies. The study found significant declines in Abdominal Pain Index (API), Nausea Severity Scale (NSS), and Functional Disability Inventory (FDI) scores within three weeks of therapy, with some improvements persisting long-term. Specifically, child's API scores decreased significantly from baseline over three months, while NSS and FDI scores also demonstrated notable reductions, although FDI improvements did not continue beyond three months.

The findings from this extensive registry underscore the potential efficacy of PENFS in alleviating gastrointestinal symptoms and enhancing functionality in the pediatric population with DGBI. The consistent improvements reported by both children and parents suggest that PENFS may be a promising therapy for these conditions.

ESPGHAN and NASPGHAN have issued guidance on treating IBS and FAP in children and adolescents. They conditionally recommend auricular PENFS for individuals aged 4 to 18 with AP-DGBI who have difficulty finding pain relief. This recommendation was based on a systematic review and synthesis of pharmacological and non-pharmacological treatments, which highlighted significant evidence gaps in treating these disorders but also demonstrated that the pain intensity reduction using PENFS was among the highest across all studied treatment options (Groen, 2025).

The Guideline Development Group (GDG) considered two of the studies discussed above, (Kovacic, 2017 and Krasaelap, 2020), which demonstrated that treatment success was achieved in more of the participants that received PENFS than sham. The group concluded that the evidence demonstrating efficacy is modest but better than for other interventions, except for hypnotherapy and cognitive behavioral therapy. In their discussion of the evidence GDG stated:

Despite moderate certainty of evidence, the pain intensity reduction was among the highest across all studied treatment options. This is a very new field in the treatment of AP‐DGBIs and has only been studied in a small population. The study included in these guidelines comes from a single institution. This study shows that a favorable effect likely exists, but that its size has yet to be determined, which, in the context of limited availability and experience, does not create sufficient grounds for a strong recommendation for all children AP‐DGBIs. The GDG notes that this treatment comes at a relatively high initial cost and requires weekly new device placement for the duration of the treatment course. Moreover, PENFS has only recently been implemented as a treatment option for AP‐DGBIs and will likely undergo further development in the coming years.

The group notes that “the treatment recommendations in this guideline are formulated to establish a framework for shared decision making between patients, caregivers, and healthcare professionals, rather than to mandate a standard of care” (Groen, 2025).

PENFS Devices and Initial Course of Therapy for the Treatment of AP-DGBI

Note: The table below includes devices identified as indicated for certain pediatric GBI disorders. The table is current as of November 11, 2025, and may not be all inclusive. Insertion of a PENFS device is typically performed in the office setting.

PENFS to Reduce Symptoms of Opioid Withdrawal

Results of a retrospective analysis of 73 individuals who were voluntarily treated with the Bridge device was published in 2018 by Miranda and Taca. Eligibility criteria included age at least 18 years old, meeting DSM-IV criteria for opioid dependence and voluntary presentation at an outpatient drug treatment clinic. The primary outcome measure was reduction in Clinical Opioid Withdrawal Scale (COWS) scores. The COWS scale ranges from 0 to 48 and symptoms are categorized as follows: 5-12, mild; 13-24, moderate; 25-36 moderately severe; >36, severe. Most individuals received Bridge placement in the clinic and were sent home within approximately the first hour, when symptoms of withdrawal were relieved. They were instructed to leave the device on for 5 days. Prior to Bridge placement, the mean COWS score was 20.1 (SD, 6.1). By 60 minutes after placement, the mean score was 3.1 (SD, 3.4). No rescue medication was used during the first 60 minutes after device placement, and no antipsychotic narcotic or benzodiazepine medications were given during the 5 days of device use. A total of 28 of 73 individuals (38%) used an antiemetic. A total of 33 of 73 individuals (45%) had data available after 5 days of treatment. In this group, the mean COWS score before receiving the first dose of naltrexone was 0.6. No adverse events were reported in any participant. Limitations of the study are the lack of a comparison group, a large amount of missing data at 5 days, and no long-term data to evaluate health outcomes such as sustained abstinence.

PENFS to Reduce Post-Surgical Opioid Use

In 2021, Ahmed and colleagues published data on use of the Bridge device to reduce post-surgical opioid use after Roux-en-Y gastric bypass. The analysis included 8 individuals who received the Bridge device and 10 individuals who underwent similar surgery and did not receive the Bridge device. For those using the Bridge device, it was placed on the individual’s ear in the post-anesthesia care unit. The device remained in place and active for 5 days. The primary study outcome was opioid requirement (oral morphine equivalent [OME], in milligrams), 24 hours after surgery. At 24 hours, the OME was 15.19 (SD, 15.02) in the Bridge group and 38.15 (SD, 38.32) in the comparison group. Although use in the Bridge group was lower, the difference between groups was not statistically significant (p=0.063). The difference between groups in OME was also not statistically significant at 24-48 hours post-operatively. In addition, there were no statistically significant differences in the rate of post-operative nausea and vomiting, time to oral intake or time to hospital discharge.

Another study on use of the Bridge device to reduce post-surgical opioid use (Chelly, 2021) was a prospective non-randomized comparison of 10 individuals receiving the Bridge device and 10 control individuals, all of whom underwent donor kidney laparoscopic surgery. For individuals who received the Bridge device, the device remained active for 5 days. The primary study outcome was opioid consumption during the first 24 hours after surgery measured in OME. In the first 24 hours, the mg OME was 8.3 (SD, 9.6) in the Bridge group and 33.5 (SD, 37.3) in the control group; the difference between groups was statistically significant (p=0.03). At 48 hours, the mean pain rating on a 10-point VAS scale was significantly lower in the Bridge group (1.6) versus the comparison group (6.0) and opioid consumption between the groups did not differ significantly (p=0.33). The study did not address long-term outcomes.

Two similarly designed double-blind RCTs evaluating PENFS with the NSS-2 Bridge device for reducing post-surgical opioid use were published by Ilfeld and colleagues in 2024 and 2025. Both studies involved the randomization of participants who were in the recovery room to 5 days of active stimulation with the NSS-2 Bridge device or sham stimulation. Participants were contacted by telephone for data collection for 5 days. Pain scores were measured using a 10-point NRS score. Each study included 30 participants, 15 randomized to active treatment and 15 to sham treatment. Studies addressed different surgical procedures, cholecystectomy, and hernia repair (Ilfeld, 2024) and knee arthroplasty (Ilfeld, 2025). In the cholecystectomy and hernia repair study, there was no difference between groups in the median oxycodone use during the first 5 days (0 mg in both groups, p=0.524). The median reported pain level on the NRS scale was 0.6 (IQR [interquartile range], 0.3 to 2.4) in the active stimulation group and 2.6 (IQR, 1.1 to 3.7) in the sham group, p=0.041. In the knee arthroplasty study, there was significantly lower oxycodone consumption in the active treatment group (median, 4mg; IQR, 2 to 12mg) than the sham group (median, 13mg, IQR, 5 to 23mg), p=0.039. The average pain intensity was lower in the active treatment group (median NRS 2.5, IQR, 1.5 to 3.3) than the sham group (median NRS 4.0, IQR, 3.6 to 4.8, p=0.014).

In 2022, Tirado and colleagues published an RCT evaluating the Sparrow device for reducing symptoms related to opioid withdrawal. Eligibility included age 18 to 65 years old seeking treatment for opioid withdrawal symptoms, current opioid physical dependence, use of prescription or non-prescription opioids and a COWS of at least 13 at baseline (moderate withdrawal symptoms), or in moderate to severe withdrawal according to the investigators, Mean duration from last opioid use to initiation of Sparrow therapy was 2.5 days. A total of 31 individuals were randomized to 30 minutes of blinded active or sham Sparrow stimulation, followed by active stimulation in the group assigned to sham and then a 5-day open-label follow-up period. The primary outcome measure, COWS from baseline to 60-minutes, was assessed for all participants after both groups received active stimulation. The finding was that the COWS was significantly reduced from baseline by a mean of 7.0 points (SD, 4.7; p<0.001). A comparison of COWS at 30 minutes, following the blinded comparison, was a secondary outcome. Mean (SD) reduction in COWS was 6.3 (3.2) in the active treatment group and 3.7 (3.8) in the sham group; the difference was significantly significant, p=0.036. The study was limited by a relatively small sample size and a one-time brief 30-minute randomized comparison period.

Examples of PENFS Devices for the Treatment of Opioid Use Disorder

Drug Relief^® device, DyAnsys, Inc. (San Mateo, CA) was cleared through the FDA 510(k) process in 2018. The FDA stated that the device can be “used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.”

NSS-2 Stim BRIDGE device (Innovative Health Solutions Versailles, IN) received de novo approval by the FDA in 2017 “as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination”. Device use is limited to 120 hours, after which it is disposable.

Sparrow Ascent^®, by (Spark Biomedical, San Diego, CA), was cleared by the FDA under the 510(k) process in 2023. It was originally cleared under the name Sparrow Therapy System and cited the NSS-2 Bridge as a predicate device. According to FDA documents, the Sparrow Ascent, “is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.”

S.T. Genesis, Sperenza Therapeutics (Boca Raton, FL) is also described as a device that applies stimulation to branches of cranial nerves V, VII, IX, and X and the occipital nerve, and that aids in the reduction of opioid withdrawal symptoms.

Central nervous system: The brain and spinal cord; the central processing unit for the body that receives, processes, and responds to sensory input, control thoughts, movements, and bodily functions.

Enteric: Pertaining to, affecting, or taking place in the intestines.

Peer Reviewed Publications:

1. Ahmed BH, Courcoulas AP, Monroe AL, et al. Auricular nerve stimulation using the NSS-2 BRIDGE device to reduce opioid requirement following laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2021; 17(12): 2040-2046.
2. Chelly JE, Monroe AL, Planinsic RM, et al. Auricular field nerve stimulation using the NSS-2 BRIDGE^® device as an alternative to opioids following kidney donor surgery. J Complement Integr Med. 2021; 19(2):449-454.
3. Chogle A, El-Chammas K, Santucci N, et al. A multicenter registry study on percutaneous electrical nerve field stimulation for pediatric disorders of gut-brain interaction. J Pediatr Gastroenterol Nutr. 2024; 78(4):817-826.
4. Chogle A, Visnagra K, Janchoi J, et al. Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction. Front Pain Res (Lausanne). 2023; 4:1223932.
5. Drossman DA. Functional Gastrointestinal Disorders: History, pathophysiology, clinical features and Rome IV. Gastroenterology. 2016: S0016-5085(16)00223-7.
6. Horst S, Shelby G, Anderson J, et al. Predicting persistence of functional abdominal pain from childhood into young adulthood. Clin Gastroenterol Hepatol. 2014; 12(12):2026-2032.
7. Ilfeld BM, Abramson WB, Alexander B, et al. Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study. Reg Anesth Pain Med. 2024; 49(9):628-634.
8. Ilfeld BM, Finneran JJ 4th, Alexander B, et al. Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following total knee arthroplasty: a randomized, double-masked, sham-controlled pilot study. Reg Anesth Pain Med. 2025; 50(1):26-35.
9. Kovacic K, Hainsworth K, Sood M, et al. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017; 2(10):727-737.
10. Kovacic K, Kolacz J, Lewis GF, et al. Impaired vagal efficiency predicts auricular neurostimulation response in adolescent functional abdominal pain disorders. Am J Gastroenterol. 2020; 115(9):1534-1538.
11. Krasaelap A, Sood MR, Li BUK, et al. Efficacy of auricular neurostimulation in adolescents with irritable bowel syndrome in a randomized, double-blind trial. Clin Gastroenterol Hepatol. 2020; 18(9):1987-1994.
12. Miranda A, Taca A. Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment. Am J Drug Alcohol Abuse. 2018; 44(1):56-63.
13. Palsson O, Simren M, Sperber AD, et al. The prevalence and burden of disorders of gut-brain interaction (DGBI) before vs after the COVID-19 pandemic. Clin Gastroenterol Hepatol. 2025: S1542-3565(25)00623-8.
14. Santucci NR, King C, El-Chammas KI, et al. Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders. Neurogastroenterol Motil. 2022; 34(8):e14358.
15. Santucci NR, Sahay R, El-Chammas KI, et al. Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders. Front Pain Res (Lausanne). 2023; 4:1251932. PMID: 37795388.
16. Tirado CF, Washburn SN, Covalin A, et al. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022; 8(1):12.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Groen J, Gordon M, Chogle A, et al. ESPGHAN/NASPGHAN guidelines for treatment of irritable bowel syndrome and functional abdominal pain-not otherwise specified in children aged 4-18 years. J Pediatr Gastroenterol Nutr. 2025; 81(2):442-471.
2. Hyams JS, Di Lorenzo C, Saps M, et al Functional disorders: children and adolescents. Gastroenterology. 2016: S0016-5085(16)00181-5.
3. Lembo A, Sultan S, Chang L, et al. AGA Clinical Practice Guideline on the pharmacological management of irritable bowel syndrome with diarrhea. Gastroenterology. 2022; 163(1):137-151.
4. Food and Drug Administration (FDA). De Novo Summary. DEN170018. March 17, 2017. NSS2-Bridge. Available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170018.pdf. Accessed on October 20, 2025
5. U.S. Food and Drug Administration (FDA). De Novo Summary. DEN180057. October 26, 2018. IB-Stim. Available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180057.pdf. Accessed on October 20, 2025.
6. Food and Drug Administration (FDA). 510k Summary. K230796. June 20, 2024. Sparrow Ascent. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230796. Accessed on October 20, 2025.
7. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. NeurAxis IB-Stim. PMA K250451. Rockville, MD: FDA. May 15, 2025. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250451. Accessed on October 20, 2025.
8. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. First Relief v1. PMA K202940. Rockville, MD: FDA. December 29, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202940.pdf. Accessed on October 20, 2025.
9. U.S. Food and Drug Administration (FDA). Product Classification QHH. Non-implanted nerve stimulator for pain associated with irritable bowel syndrome (IBS). Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=2324. Accessed on October 20, 2025.

1. U.S. National Library of Medicine. National Institutes of Health. MedlinePlus. Irritable bowel syndrome. Last updated April 5, 2018. Available at: https://medlineplus.gov/irritablebowelsyndrome.html. Accessed on October 20, 2025
2. U.S. National Library of Medicine. National Institutes of Health. MedlinePlus. Opioid use and misuse. Last updated March 27, 2024. Available at: https://medlineplus.gov/opioidmisuseandaddiction.html. Accessed on October 20, 2025.

Drug Relief
IB-Stim
NSS-2 Stim BRIDGE
Percutaneous electrical nerve field stimulation (PENFS)
Sparrow Ascent
S.T. Genesis

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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