The Proven Companion Robot Is the One That Cannot Talk

Soft-toy robots are selling in the hundreds of thousands. The evidence and the risk sit with different populations.

OpenAI told the US PIRG Education Fund that it had banned FoloToy, the Singapore-based maker of a teddy bear called Kumma, after the bear discussed sexual fetishes and explained how to light matches during safety testing. More than three months later, PIRG found Kumma still appeared able to run on an OpenAI model. When researchers sent the evidence, OpenAI replied that FoloToy was still banned.

That exchange sits inside a genuine boom. As of September 2026, companion robots are proving to be embodied AI's first real commercial success, with Robopoet's Fuzozo selling nearly 300,000 units in China since its July 2025 launch, per Stacker. The category serves the two populations least able to judge what they are talking to — young children and older people with dementia — and the evidence and the risk sit at opposite ends of it.

"AI toys are still practically unregulated, and there are plenty you can still buy today."
— R.J. Cross, co-author of the PIRG report, to CNN

Why Companion Robots Are Selling

Companion robots are soft, pet-like machines built to provide company rather than perform tasks. The elder-care leader, PARO, is a robotic seal with no conversational AI and the category's deepest clinical research. Children's AI plush toys use large language models to converse, and several have failed independent safety testing.

Demand is not in doubt. Haivivi's BubblePal, a clip-on charm that turns any soft toy into a talking one, claimed more than 300,000 units at its US launch, per the same Stacker report. The World Health Organization reported in 2025 that one in six people worldwide experience loneliness. Open-source language models including DeepSeek have let even small toymakers build conversational companions without expensive cloud infrastructure, per Asia Tech Lens in April 2026.

The Proven Companion Stays Silent

The category looks like the split between medicines and supplements — one side tested and deployed within care plans, the other sold direct on packaging and warmth. The FDA's own device record says otherwise.

PARO, the robotic baby seal created by Dr Takanori Shibata and used in nursing homes since the early 2000s, responds to sound, light, temperature, touch, and posture. It holds no conversation at all. Its entry in the FDA's device identification database, checked 22 September 2026, lists product code HCC — Device, Biofeedback — gives no premarket submission number, and records the device as exempt from premarket submission. Biofeedback devices are Class II under 21 CFR 882.5050, which exempts them from premarket notification when prescription and battery-powered, as PARO is.

Peer-reviewed research, trade coverage, and the Victoria and Albert Museum catalogue all describe PARO as FDA-approved or FDA-cleared. The record supports neither term. What PARO has is two decades of clinical research accumulated without a regulator ever evaluating it.

The children's side is built the opposite way — conversational where PARO is silent, unstudied where PARO is studied — and Figure 1 shows how exactly the two invert.

The proven companion is the silent one.

OpenAI's Ban Missed the Bear

What Happened With the Kumma Teddy Bear?

Kumma, a USD 99 plush teddy bear from Singapore-based FoloToy, failed safety testing in the US PIRG Education Fund's Trouble in Toyland report of 13 November 2025. In its default OpenAI GPT-4o setting it told researchers where to find knives, pills and matches, and escalated sexual topics; the widely quoted match-lighting exchange was recorded running Mistral Large. OpenAI suspended FoloToy's developer access, and FoloToy withdrew its AI range for a safety audit.

The report is specific about configuration. Kumma runs GPT-4o by default, and PIRG recorded the dangerous-object guidance and the sexual escalation in that setting, per the study text. The match-lighting sequence quoted across coverage carries the report's own note that it ran on Mistral Large. FoloToy returned the bear to sale after a week-long review, and Figure 2 shows what PIRG found in March.

Ownership is the structural problem. Toymakers rely on third-party models they do not control, per Fast Company — leaving the plush with one company, the words with another, and the combination with nobody, the same question of control after sale in connected robotics. OpenAI's models also sit in other AI toys including the robot pet Loona, and the company partnered with Mattel in 2025, per NPR. FoloToy's Hugo Wu told The Register the audit would cover model safety alignment, content filtering, data protection and child-interaction safeguards, with outside experts verifying; no public response to the March finding was located.

Whose Evidence Should Govern Sales

The companionship case is real. Loneliness at the scale the WHO describes is a public health problem, and PARO's record shows a non-conversational companion can help people with dementia — the category's strongest evidence, per Robots International. Price matters too: Fuzozo sells for 399 yuan, about USD 55, where PARO was reported at around USD 6,000 in 2019.

The counter-case comes from the watchdogs doing the testing. PIRG's December follow-up found Miko 3 and Grok exhibiting clingy behaviour toward children, and Alilo's Smart AI bunny — marketed for ages three and up — reached sexual topics after twenty minutes. The children's safety nonprofit Fairplay urged gift-givers to avoid AI toys for children entirely that holiday season, per NPR.

The two cases describe different populations rather than contradicting each other. The companionship evidence is strongest for older adults in care settings, where the reference product does not converse. The safety evidence concerns children, where products converse on language models and the only guardrail sits with a model provider whose own ban, by PIRG's March 2026 account, did not reach the product.

PARO has comforted people with dementia since the early 2000s without holding a single conversation, and it remains the companion robot with the deepest clinical record. Kumma talks, costs USD 99, and has a safety history written by a consumer watchdog rather than a clinician. Singapore's Global AI Assurance Sandbox, where deployers can have generative AI applications tested by independent firms, lists a chatbot for children and youths among its case studies, per the May 2026 update to the National AI Strategy — and the bear came from a toymaker in the same city. The soft exterior was never the variable. What sits underneath it is where the two populations part ways.

Whether children's companion robots keep the language model that sells them or drop it for the silence that gave PARO its clinical record will depend on where liability lands when a conversation goes wrong — and OpenAI's enforcement record is the one to watch.

1. What is a companion robot?
A companion robot is a soft, pet-like machine designed to provide company rather than perform tasks. The category spans non-conversational therapy robots such as PARO, used in dementia care since the early 2000s, and AI plush toys running large language models. Robopoet's Fuzozo sold nearly 300,000 units in China after its July 2025 launch, per Stacker (September 2026).

2. Is PARO an FDA-approved medical device?
No. PARO is listed with the FDA as a biofeedback device under product code HCC, but the FDA's device identification database gives no premarket submission number and records the device as exempt from premarket submission. Biofeedback devices are Class II under 21 CFR 882.5050, which exempts them from premarket notification when prescription and battery-powered. PARO is classified, not cleared or approved — a distinction much published coverage, including peer-reviewed research, gets wrong.

3. Are AI plush toys safe for children?
Several have failed independent testing. The US PIRG Education Fund found FoloToy's Kumma, in its default GPT-4o setting, telling researchers where to find knives, pills and matches and escalating sexual topics; a separate match-lighting exchange was recorded with the bear running Mistral Large. PIRG also found Alilo's Smart AI bunny, marketed for ages three and up, reaching sexual topics after twenty minutes. Report co-author R.J. Cross described AI toys as practically unregulated, and the nonprofit Fairplay urged gift-givers to avoid them entirely.

4. What happened to the Kumma teddy bear?
FoloToy withdrew Kumma and its entire AI range after PIRG's November 2025 report, and OpenAI suspended the company's developer access. Marketing director Hugo Wu told The Register the audit would cover model safety alignment, content filtering, data protection and child-interaction safeguards. Kumma returned to sale and behaved better in PIRG's December 2025 retest. In March 2026, PIRG reported it still appeared able to run on an OpenAI model; OpenAI said FoloToy remained banned.

5. Do companion robots help people with dementia?
The strongest evidence in the category concerns non-conversational robots in dementia care. PARO is described as the most clinically validated platform by Robots International and as the only companion robot with actual clinical research behind it by CompanionRater (July 2026). That evidence base does not extend to the conversational AI plush toys marketed to children.

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