Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator

The REALITY study is a post-market, prospective, non-randomized, single-arm, open-label
study. It is intended to collect short- and long-term safety and effectiveness data on
various populations implanted with Abbott's neurostimulation systems. This study has broad
inclusion criteria and minimal exclusion criteria to ensure the results are representative of
the real-world use of these devices. Enrollment caps will be implemented to ensure patients
from approved indications are represented. Individuals who are scheduled to receive an
implantable Abbott neurostimulation system are eligible for study consideration.

Inclusion Criteria:

- Subject must provide written informed consent prior to any clinical investigation
related procedure.

- Subject is at least 18 years (or the minimum age required by local law to consent for
participation in a clinical investigation) or older at the time of enrollment.

- Subject is scheduled to have an Abbott neurostimulation system implanted within 30
days.

Exclusion Criteria:

- Subject is enrolled, or intends to participate, in a competing clinical study, as
determined by Abbott.

- Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements.

- Subject is part of a vulnerable population including incapacitated individuals,
individuals unable to read or write, individuals under the age of legal consent, and
pregnant or breastfeeding women.