TED (TransEpidermal Delivery)
TransEpidermal Delivery (TED) is a technology designed to enhance the penetration of topical preparations through the skin without the use of needles or surgical incisions. In hair restoration, the approach has gained attention through the original Alma TED system, which uses acoustic energy to temporarily modify the skin’s permeability and facilitate the delivery of specialized topical formulations to the scalp.
The technology is frequently promoted as a comfortable, non-invasive alternative to treatments involving injections or other procedures that physically penetrate the skin. However, an important distinction must be made between a technology that enhances the delivery of topical substances and a treatment that has been demonstrated to produce meaningful hair regrowth.
Although ultrasound-assisted drug delivery has an established scientific foundation, the clinical evidence supporting commercial TED protocols for androgenetic alopecia remains limited. Questions persist regarding the effectiveness of the proprietary formulations being administered, the durability of reported improvements and whether the complete treatment offers meaningful advantages over established medical therapies.
The American Hair Loss Association considers TED an interesting technological approach that warrants further investigation. However, its growing availability in medical practices should not be confused with established evidence that TED-based treatments consistently reverse follicular miniaturization or produce lasting cosmetic improvement.
History of TransEpidermal Delivery
The concept of enhancing drug penetration through the skin has been investigated for decades. Researchers have explored various technologies intended to overcome the protective barrier of the outermost layer of the epidermis, known as the stratum corneum.
These approaches include iontophoresis, which uses electrical current; electroporation, which uses electrical pulses; and sonophoresis, which uses ultrasound energy. Although all are intended to improve the passage of substances through the skin, they employ different mechanisms and should not be considered interchangeable.
Ultrasound-assisted transdermal delivery has attracted scientific interest because certain ultrasound frequencies and treatment parameters can temporarily influence skin permeability without requiring needles. Researchers have investigated these effects for delivering pharmaceutical compounds and other therapeutic substances.
More recently, manufacturers began adapting acoustic delivery technologies for cosmetic and hair restoration applications. Alma TED emerged as one commercial system designed to combine ultrasound-assisted delivery with proprietary topical preparations marketed to support scalp health and hair growth.
The system’s introduction has been accompanied by increasing promotion among dermatology, aesthetic medicine and hair restoration practices. However, commercial adoption has occurred while substantial questions remain about the efficacy, safety and long-term value of the complete treatment protocol.
How Does TED Work?
The original Alma TED system uses acoustic energy, including low-frequency ultrasound, to influence the permeability of the scalp’s outer protective barrier. The intended effect is to facilitate the movement of ingredients from a topical preparation into superficial skin tissue.
Ultrasound-assisted delivery is commonly described as sonophoresis. Depending on the frequency, intensity and treatment conditions, acoustic energy can influence the organization of lipids within the stratum corneum and modify pathways through which substances pass.
Researchers have proposed several mechanisms, including acoustic cavitation and other mechanical effects that can temporarily alter the skin barrier. These processes have been investigated in the broader field of transdermal drug delivery, although the relative contribution of each mechanism under the specific conditions used by commercial scalp treatment systems has not been fully established.
Unlike microneedling, conventional TED does not rely on physically puncturing the skin with needles. However, describing a procedure as non-invasive does not establish that it is biologically inactive or that every substance delivered through the altered skin barrier is necessarily safe.
The degree of increased penetration may vary according to the device settings, characteristics of the skin and chemical properties of the applied formulation.
More importantly, improving the penetration of a substance does not establish that the substance itself is effective for treating hair loss.
A device may successfully enhance delivery without producing a clinically meaningful effect on androgenetic alopecia. The biological activity, concentration, stability and therapeutic relevance of the delivered ingredients must be independently established.
What Ingredients Are Used With TED?
One of the most significant questions surrounding TED-based hair restoration concerns the preparations administered during treatment.
The original Alma TED system has been marketed alongside proprietary cosmetic formulations containing peptides and other ingredients promoted as supporting scalp health and follicular activity. Some TED-based protocols may also be advertised as delivering growth factors or other biologically active substances. However, these ingredients differ in composition, biological activity and supporting clinical evidence, and findings involving one formulation cannot automatically be applied to another.
The presence of ingredients associated with cellular signaling or tissue repair does not establish that a formulation can reverse androgenetic alopecia.
Pattern hair loss is a progressive condition involving genetic susceptibility, androgen signaling and the gradual miniaturization of susceptible follicles. Successfully treating this process requires more than demonstrating that an ingredient participates in normal biological activity.
For any TED-based preparation, important questions include whether the ingredients have demonstrated clinically meaningful effects on human scalp follicles, whether the concentrations used are appropriate and whether the complete formulation has undergone controlled clinical evaluation.
It is equally important to determine whether the preparation being used in a particular medical practice is identical to the formulation evaluated in published research.
Practitioners may offer different products or treatment combinations, making it inappropriate to generalize results obtained with one preparation to other formulations.
The AHLA cautions consumers against assuming that a proprietary formulation is effective simply because it contains peptides, growth factors or other biologically active ingredients. The complete treatment must be supported by meaningful clinical evidence.
What Does the Clinical Evidence Show?
Research investigating ultrasound-assisted delivery provides a scientific basis for the possibility of increasing skin permeability. However, demonstrating enhanced penetration is fundamentally different from establishing effective treatment for androgenetic alopecia.
Early clinical evaluations of the original Alma TED system have reported improvements in hair density and patient satisfaction when the device was used in combination with proprietary topical preparations.
One manufacturer-associated, two-center evaluation enrolled 33 individuals with male or female pattern hair loss, including 30 women and three men. A total of 31 participants, including 29 women and two men, completed follow-up. The evaluation used three monthly treatments combining Alma TED with a peptide-based topical formulation.
Investigators reported average improvements in measured hair density of approximately 23% at the first follow-up and 31% at the six-month follow-up. The report also described increases in terminal hair counts of approximately 13% and 23% at those respective follow-ups. No treatment-related adverse events were reported during the evaluation.
These percentages represent relative changes in measured hair density within a small, uncontrolled evaluation and should not be interpreted as equivalent improvements in visible scalp coverage. Because only two men completed the study, the findings also provide very limited evidence regarding effectiveness in male androgenetic alopecia.
The results were presented in a manufacturer-associated clinical white paper rather than a large, independently replicated randomized controlled trial. Although the reported improvements warrant investigation, they must be interpreted in the context of the study’s limitations.
The evaluation was open-label and did not incorporate an untreated or sham-treated comparison group. Without appropriate controls, it is difficult to determine how much of the reported improvement resulted from the ultrasound device, the topical formulation, other influences or variation in hair measurements.
A separate publication appearing in Dermatologic Surgery in August 2026 examined ultrasound-assisted transepidermal delivery of growth factors for androgenetic alopecia. Although it contributes to the developing literature, additional independent, controlled studies are needed to determine whether the approach produces reproducible, clinically meaningful and sustained improvements in hair growth.
The available evidence has not established that TED consistently produces clinically meaningful hair regrowth across different patient populations, formulations and treatment schedules.
Nor has it adequately demonstrated that observed improvements are maintained over several years or that TED offers superior outcomes compared with established medical therapies.
These limitations are particularly important because manufacturers and medical practices may promote favorable percentage increases in hair density without explaining the study design, number of participants or clinical significance of the findings.
Does TED Treat Androgenetic Alopecia?
Androgenetic alopecia is characterized by progressive follicular miniaturization in genetically susceptible individuals. In men, androgen signaling involving dihydrotestosterone plays a central role in this process.
Effective treatment requires an intervention capable of meaningfully influencing the mechanisms responsible for follicular miniaturization, maintaining existing hair or promoting sustained regrowth.
TED itself is primarily a delivery technology. Its potential effectiveness depends on what is being delivered and whether the substance reaches its intended target in a biologically effective concentration.
A topical preparation containing peptides or other growth-related compounds may be marketed as supporting follicular activity. However, unless appropriately controlled human studies demonstrate that the complete protocol produces meaningful and reproducible improvements in androgenetic alopecia, the treatment should not be regarded as established.
This distinction also applies to formulations containing known medications. If a medication has demonstrated efficacy when used conventionally, that does not automatically establish that ultrasound-assisted delivery improves its effectiveness or safety.
Similarly, enhanced penetration could alter exposure to a drug without necessarily improving clinical outcomes.
Patients should understand that a plausible delivery mechanism is only one component of an effective treatment. The substance being delivered, its biological activity and the clinical results achieved with the complete protocol are equally important.
FDA Clearance and Regulatory Considerations
The regulatory status of TED requires careful consideration, particularly because different technologies are now marketed under similar product names.
The original Alma TED system uses ultrasound-based acoustic energy to facilitate the delivery of topical formulations into the scalp. The clinical effectiveness of this approach depends not only on the delivery technology but also on the ingredients administered and the evidence supporting the complete treatment protocol.
In June 2026, the FDA granted 510(k) clearance to a newer system called Alma TED+ for specified hair growth indications in men and women with androgenetic alopecia. However, the cleared TED+ system uses low-level laser therapy operating at a wavelength of 650 nanometers, rather than relying on the ultrasound-assisted delivery mechanism associated with the original Alma TED treatment.
Low-level laser therapy is a separate treatment category with its own body of clinical research, discussed in greater detail in the AHLA’s Low-Level Laser Light Therapy (LLLT) for Hair Loss section.
The FDA’s substantial-equivalence determination for TED+ relied on comparison with a previously cleared laser hair-growth device. It did not establish the clinical effectiveness of the original ultrasound-based TED treatment or the proprietary topical preparations associated with that procedure.
The FDA clearance of Alma TED+ should not be interpreted as validation of the original ultrasound-based Alma TED system or the proprietary topical formulations administered with it. The two technologies have different mechanisms of action, and evidence supporting one cannot automatically be applied to the other.
FDA clearance through the 510(k) pathway generally establishes substantial equivalence to an appropriate legally marketed device for its specified intended use. It does not establish that every product, formulation or treatment protocol marketed under a related brand name has demonstrated equivalent effectiveness.
The AHLA encourages consumers to ask practitioners which technology is being used, whether the specific device has FDA clearance for hair growth, what ingredients are being administered and what independent clinical evidence supports the complete treatment.
Safety and Long-Term Considerations
Ultrasound-assisted topical delivery is generally promoted as a comfortable procedure that does not require needles, injections or surgical incisions.
Early evaluations of the original Alma TED system have reported favorable short-term tolerability, with little or no treatment-related discomfort among participants.
However, relatively small clinical evaluations cannot fully establish the safety of repeated treatments over extended periods or the risks associated with the many formulations practitioners may choose to administer.
Temporarily altering the skin barrier can change how substances interact with scalp tissue. The consequences depend on the ingredients involved, their concentrations, the delivery parameters and individual patient characteristics.
Potential concerns include irritation, contact sensitivity, unexpected reactions to topical ingredients and altered absorption of substances not adequately studied for enhanced delivery.
It would be inappropriate to assume that such complications occur frequently with TED, since the available clinical literature does not establish that conclusion. Nevertheless, the absence of significant adverse events in small, short-term studies should not be interpreted as comprehensive proof of long-term safety.
Additional uncertainty surrounds the durability of treatment results. Existing evaluations have not adequately established whether repeated sessions are necessary to maintain improvement, how frequently those sessions might be required or whether treatment discontinuation leads to a loss of any observed benefit.
Although the manufacturer-associated clinical report suggested that maintenance treatments might be required every three to six months, this schedule was not established through controlled studies demonstrating how frequently treatment must be repeated to preserve any benefit.
Consumers should also consider the financial implications of undergoing a series of in-office treatments, particularly when the expected degree and duration of cosmetic improvement remain uncertain.
How Does TED Compare With Established Hair Loss Treatments?
Unlike finasteride and minoxidil, which have been investigated extensively in clinical trials and used in the treatment of androgenetic alopecia for decades, TED-based hair restoration protocols have a comparatively limited clinical evidence base.
Finasteride has an established role in reducing androgen-mediated follicular miniaturization in appropriately selected men, while minoxidil can promote hair growth through mechanisms that remain incompletely understood.
These treatments have known limitations and potential adverse effects, but their effectiveness has been evaluated through substantially larger bodies of clinical research.
TED does not currently have comparable evidence demonstrating reliable long-term control of androgenetic alopecia.
It also has not been established that using TED alongside finasteride or minoxidil consistently produces meaningful additional benefits.
Patients should therefore be cautious about substituting TED for established therapies, particularly when doing so could delay treatment during a period of progressive follicular miniaturization.
The AHLA believes that emerging delivery technologies should be judged according to demonstrable clinical outcomes rather than theoretical advantages or the commercial appeal of a needle-free procedure.
The AHLA Perspective
The American Hair Loss Association recognizes that ultrasound-assisted delivery is a scientifically legitimate area of investigation and that the original Alma TED system represents an interesting application of this technology to hair restoration.
Preliminary clinical evaluations have reported improvements in measured hair density when ultrasound-assisted delivery is combined with certain proprietary topical formulations. These findings warrant additional investigation, but they do not yet establish the long-term effectiveness, reproducibility or comparative value of TED-based treatment for androgenetic alopecia.
Of particular concern is the assumption that enhanced delivery of growth-related ingredients necessarily translates into meaningful hair regrowth. The composition, biological activity and clinical effectiveness of the preparation being delivered are central to evaluating the treatment.
The growing number of clinics offering TED should not be mistaken for proof of efficacy. Commercial adoption, patient testimonials and favorable manufacturer-associated evaluations cannot replace appropriately controlled clinical trials.
Consumers should also distinguish the original ultrasound-based Alma TED system from newer technologies marketed under related names, particularly when manufacturers reference FDA clearance or clinical findings involving devices with different mechanisms of action.
The AHLA encourages patients to seek an accurate diagnosis and consider established medical treatments before investing in procedures whose long-term value remains uncertain.
The AHLA does not currently recommend TED as an established treatment for androgenetic alopecia. While the technology deserves continued scientific investigation, consumers should be cautious about claims of significant or lasting hair regrowth until the complete treatment protocols, including the specific formulations being delivered, have been evaluated in rigorous, appropriately controlled clinical studies.
Selected References
1. Polat BE, et al. Ultrasound-Mediated Transdermal Drug Delivery: Mechanisms, Scope, and Emerging Trends. Journal of Controlled Release. 2011. PubMed
2. Han S, Erkhembaatar N, Tavares L. Ultrasound-Assisted Transepidermal Delivery of Growth Factors for Hair Regrowth in Androgenetic Alopecia. Dermatologic Surgery. 2026. PubMed
3. Bauman AJ, Desai S. A 6-month Dual-center Study Evaluating Alma TED and a Peptide-based Topical Hair Care Formula for Female and Male Pattern Hair Loss. Manufacturer-associated clinical white paper. 2024. Clinical Report
4. U.S. Food and Drug Administration. Alma TED+ System, 510(k) Summary and Indications for Use, K251684. 2026. FDA
Used for: Male Pattern Baldness, Female Pattern Baldness