Clinical Research|Articles in Press

Accessibility and Ease of Use in Neuromodulation Devices



      The utilization of neuromodulation therapy continues to grow as therapeutic indications expand. These conditions often present with comorbid physical, visual, and auditory impairments. Patients with disabilities in these categories may have difficulty operating their devices. Thus, reviewing the accessibility and inclusive design of neuromodulation devices is imperative to ensure equal access for patients of all ability levels. To date, the literature provides little insight into this topic.

      Materials and Methods

      Manufacturers of Food and Drug Administration-approved neuromodulation devices in the United States completed our electronic survey to assess neuromodulation device features, universal/inclusive design guidelines, and methods used to make the device accessible to patients with disabilities.


      We assessed 11 devices from seven manufacturers. Of those, there were six spinal cord, two peripheral nerve, and three deep brain stimulators. Of all respondents, 91% used universal inclusive design guidelines. Of the studied devices, 91% have an interface that uses visual feedback, and 82% have an interface that uses auditory feedback. All surveyed devices were reported to have an interface that requires physical handling.


      Our study found that most devices incorporate auditory signals, buttons with raised indentations, speech commands, or other useful features to assist those with visual disabilities. Visual interfaces may be sufficient for a patient with hearing impairment to use all the surveyed devices. However, dual sensory impairment presents a significant limitation in all devices surveyed. Furthermore, the biggest barrier to using neuromodulation devices was physical impairment because all surveyed devices require physical handling.


      Manufacturers have awareness of universal inclusive design principles. However, our study was unable to find a device that is accessible to all users regardless of ability. As such, it is critical to involve universal design principles to ensure that inclusive devices are available to improve patient adherence, treatment efficacy, and outcomes.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Luan S.
        • Williams I.
        • Nikolic K.
        • Constandinou T.G.
        Neuromodulation: present and emerging methods.
        Front Neuroeng. 2014; 7: 27
        • Vakkala M.
        • Järvimäki V.
        • Kautiainen H.
        • Haanpää M.
        • Alahuhta S.
        Incidence and predictive factors of spinal cord stimulation treatment after lumbar spine surgery.
        J Pain Res. 2017; 10: 2405-2411
        • Fishman M.A.
        • Antony A.
        • Esposito M.
        • Deer T.
        • Levy R.
        The evolution of neuromodulation in the treatment of chronic pain: forward-looking perspectives.
        Pain Med. 2019; 20: S58-S68
        • Malinowski M.N.
        • Chopra P.R.
        • Tieppo Francio V.
        • Budwany R.
        • Deer T.R.
        A narrative review and future considerations of spinal cord stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation.
        Curr Opin Anaesthesiol. 2021; 34: 774-780
        • Chou C.Y.
        • Chiu C.J.
        • Chang C.M.
        • et al.
        Disease-related disability burden: a comparison of seven chronic conditions in middle-aged and older adults.
        BMC Geriatr. 2021; 21: 201
        • Edwards C.A.
        • Kouzani A.
        • Lee K.H.
        • Ross E.K.
        Neurostimulation devices for the treatment of neurologic disorders.
        Mayo Clin Proc. 2017; 92: 1427-1444
        • Bitterman N.
        Design of Medical Devices—a home perspective.
        Eur J Intern Med. 2011; 22: 39-42
        • Patrick V.M.
        • Hollenbeck C.R.
        Designing for all: consumer response to inclusive design.
        J Consum Psychol. 2021; 31: 360-381
        • Hagedorn T.J.
        • Krishnamurty S.
        • Grosse I.R.
        An information model to support user-centered design of medical devices.
        J Biomed Inform. 2016; 62: 181-194
        • Boersma P.
        • Black L.I.
        • Ward B.W.
        Prevalence of multiple chronic conditions among US adults, 2018.
        Prev Chronic Dis. 2020; 17: E106
        • Yong R.J.
        • Mullins P.M.
        • Bhattacharyya N.
        Prevalence of chronic pain among adults in the United States.
        Pain. 2022; 163: e328-e332
      1. National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). Encyclopedia of Global Health. Sage Publications, 2008
      2. Fast facts about vision loss. Centers for Disease Control and Prevention.
        (Accessed August 21, 2022)
        • Birch J.
        Worldwide prevalence of red-green color deficiency.
        J Opt Soc Am A Opt Image Sci Vis. 2012; 29: 313-320
        • Lin F.R.
        • Niparko J.K.
        • Ferrucci L.
        Hearing loss prevalence in the United States.
        Arch Intern Med. 2011; 171: 1851-1852
        • Leveziel N.
        • Marillet S.
        • Braithwaite T.
        • et al.
        Self-reported dual sensory impairment and related factors: a European population-based cross-sectional survey.
        Br J Ophthalmol. Published online February 9. 2023;
        • Louis E.D.
        • McCreary M.
        How common is essential tremor? update on the worldwide prevalence of essential tremor.
        Tremor Other Hyperkinet Mov (N Y). 2021; 11: 28
        • Hicks C.W.
        • Wang D.
        • Windham B.G.
        • Matsushita K.
        • Selvin E.
        Prevalence of peripheral neuropathy defined by monofilament insensitivity in middle-aged and older adults in two US cohorts.
        Sci Rep. 2021; 1119159
      3. Gelzayd E. Spinal cord stimulation trial in a visually impaired patient. Poster presented at: North American Neuromodulation Society 26th Annual Meeting; January 12–15, 2023; Las Vegas, Nevada.

      4. Gardner-Bonneau D. The United States’ journey to achieve accessibility of medical devices. Paper presented at: Proceedings of the 20th Congress of the International Ergonomics Association; August 26–30, 2018; Florence, Italy.

      5. Americans with disabilities act of 1990 (United States).
        in: Albrecht G.L. Encyclopedia of Disability. Sage Publications, 2006
      6. Rehabilitation act of 1973 (United States).
        in: Albrecht G.L. Encyclopedia of Disability. Sage Publications, 2006
        • Story M.F.
        Applying the principles of universal design to medical devices.
        in: Medical Instrumentation. CRC Press, 2006: 83-92
        • Wilcox S.
        Home healthcare: Applying inclusive design principles to medical devices.
        in: Designing Usability Into Medical Products. CRC Press, 2005: 227-234
        • Petersen E.A.
        • Stauss T.G.
        • Scowcroft J.A.
        • et al.
        Effect of high-frequency (10-KHz) spinal cord stimulation in patients with painful diabetic neuropathy: a randomized clinical trial.
        JAMA Neurol. 2021; 78: 687-698
        • Smith R.O.
        • Barnekow K.
        • Lemke M.R.
        • et al.
        Development of the Medical Equipment Device Accessibility and universal design information tool.
        in: Medical Instrumentation. CRC Press, 2006: 283-296
      7. MED-AUDIT (Medical Equipment Device–Accessibility and Universal Design Information Tool): usability analysis. 29th Annual RESNA Conference Proceedings. Accessed August 21, 2022.