CurrentUnitedHealthcarePolicy CS052KY.11

Hearing Instruments and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Kentucky Only)

Medical policy governing coverage and clinical criteria for wearable air-conduction hearing aids, bone-anchored/bone conduction devices, and semi-implantable hearing aids for UnitedHealthcare Community Plan members in Kentucky; applies to providers and claims for those products in Kentucky.

Policy Summary

PayerUnitedHealthcare

PolicyHearing Instruments and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Kentucky Only)

Policy CodePolicy CS052KY.11

Change TypeCPT code list updated

Effective DateDecember 1, 2025

Next Review Date

Key ActionObtain prior authorization using InterQual clinical criteria and document device-specific FDA selection criteria when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable CPT codes to reflect quarterly edits; added 0951T, 0952T, 0953T, 0954T, and 0955T

Archived previous policy version CS052KY.10

Kentucky-onlystate-specific

InterQual referencedInterQual

MultipleFDA-cleared devices

SeveralUnproven devices listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Policy history entries

Coverage and Medical Necessity Criteria

inv-01: Covered when InterQual criteria met — Wearable air-conduction hearing aids

Covered when ALL of the following are met:

Wearable air-conduction hearing aids required for the correction of a hearing impairment are proven and medically necessary.

For specific clinical coverage criteria and prior authorization, refer to InterQual CP: Durable Medical Equipment, Hearing Aids.

inv-02: Covered when InterQual criteria met — Bone-anchored / bone conduction devices

Covered when ALL of the following are met:

Bone-anchored/bone conduction devices: Medical necessity clinical coverage criteria are determined by InterQual CP: Procedures — Hearing Device, Bone Anchored or Bone Conduction (including pediatric criteria where applicable).

Refer to InterQual for specific inclusion/exclusion, device-specific numeric thresholds, and prior authorization requirements.

inv-03: Covered when InterQual criteria met — Semi-implantable hearing aids

Covered when ALL of the following are met:

Semi-implantable electromagnetic hearing aids: Medical necessity clinical coverage criteria are determined by InterQual CP: Procedures, Hearing Device, Middle Ear.

Refer to InterQual for device-specific indications, audiologic thresholds, and prior authorization requirements.

inv-04: Coverage and evidence summaries by device type — coverage stance varies by device type and evidence quality

Coverage stance varies by device type and quality of evidence; where evidence is insufficient the device is not supported, and FDA labeling/AAO-HNS guidance is referenced for appropriate use.

Intraoral bone conduction hearing aids (IOBC): Evidence is insufficient to support use to treat hearing loss; available studies were low quality (small populations, short follow-up, lack of randomization and appropriate control groups).

See source evidence summary and exclusion statements.

Totally implantable middle ear systems (e.g., Carina, Esteem): Identified evidence is limited and mixed with lack of concurrent comparison groups and reports of adverse events; insufficient high-quality evidence to definitively establish efficacy.

AAO-HNS recognizes active middle ear implants as appropriate for selected adults when conventional amplification is inadequate; adhere to FDA restrictions and professional guidance.

Laser/light-based contact hearing devices (Earlens): Some single-arm and nonrandomized studies report benefit and the device has FDA clearance for adults meeting device labeling, but comparative benefit versus conventional hearing aids requires further study.

inv-05: Covered when device meets FDA-indicated patient criteria — device-specific FDA indications aggregated

Device-specific FDA indications (examples aggregated from document):

Device indications summary: Coverage is contingent on meeting device-specific FDA labeling, which commonly includes: minimum age (device dependent), audiologic criteria such as PTA bone-conduction thresholds within device-specific limits (examples: <=25 dB HL for ADHEAR; <=45 dB HL or <=55 dB HL for various BAHA/Bonebridge/Osia configurations), pure tone air-conduction thresholds for SSD contralateral ear commonly <=20 dB HL, word recognition score requirements (eg, Vibrant Soundbridge >=50%), and bilateral symmetry requirements (eg, <10 dB average difference or <15 dB at individual frequencies).See thresholds and device sections for numeric examples

Each device (Vibrant Soundbridge, Maxum, BAHA/Ponto/Sophono/Bonebridge/Osia/ADHEAR/Earlens/others) has distinct numeric criteria documented in FDA labeling; consult the specific device labeling and InterQual when submitting prior authorization requests.

The policy lists specific device types that are considered unproven due to insufficient evidence of efficacy: Intraoral bone conduction hearing instruments (e.g., SoundBite), laser or light-based contact hearing devices (CHD; e.g., Earlens), and totally implanted middle ear hearing instruments. These device categories are identified in the coverage section as lacking adequate high-quality evidence to support routine treatment of hearing loss and therefore are not supported by the evidence base summarized in this policy.

Where evidence is insufficient, the policy indicates these device types may be treated as not medically necessary for the treatment of hearing loss; coverage determinations should follow applicable InterQual criteria and plan, federal, or state contractual terms noted elsewhere in this policy.

For laser or light-based contact hearing devices (CHD) such as the Earlens system, the policy summarizes that the technology uses a behind-the-ear processor to convert sound into infrared light transmitted to a tympanic membrane transducer which produces mechanical vibrations. Although FDA clearance was obtained based on safety and effectiveness data, available studies are primarily single-arm or nonrandomized; comparative benefit versus conventional hearing aids requires further high-quality study before broader coverage can be assumed.

For intraoral bone conduction hearing aids (IOBC) like the SoundBite, the policy notes the proposed mechanism (sound transmission via teeth and skull bones) but states the published studies are low quality (small samples, short follow-up, lack of randomization and appropriate control groups), and therefore the evidence is insufficient to establish effectiveness for treating hearing loss.

The SoundBite™ Intraoral Bone Conduction Hearing System is no longer manufactured. Sonitus Medical (the manufacturer) filed bankruptcy and ceased manufacturing of the SoundBite system in 2015, and the policy notes there is no new information indicating resumed production.

Because the SoundBite device is not being produced, it is not available as a commercially supported treatment option and should not be relied upon in coverage decisions except as historical context.

The policy explicitly lists the following devices as unproven / not medically necessary for treatment of hearing loss due to insufficient evidence: Intraoral bone conduction hearing instruments (e.g., SoundBite), laser or light-based hearing instruments (e.g., Earlens CHD), and totally implanted middle ear hearing instruments.

These device types are identified because the available studies are limited by small sample sizes, short follow-up, single-arm designs, lack of appropriate controls, and conflicting findings including reported adverse events for some totally implanted systems.

The policy reiterates that intraoral bone conduction (IOBC) devices have insufficient quality evidence to support their use in treating hearing loss. Published studies are described as low quality (small populations, short follow-up, and lack of randomization or appropriate control groups), which supports the policy’s stance that IOBC devices are not supported by current evidence.

Given the limited and low-quality evidence base and the fact that the SoundBite system is no longer manufactured, claims for IOBC devices may be at risk for denial or considered non-covered when presented as medically necessary without stronger supporting data.

Coverage determinations should be made in the context of the member’s applicable benefit terms. This Medical Policy is informational and states that plan, federal, or state contractual requirements govern coverage decisions and may differ from the policy’s general statements; in the event of conflict, the federal, state, or contractual requirements govern.

Applicable Procedure, Supply and Billing Codes

Bone Anchored Hearing Aids (BAHA) CPTCPT

69710	Implantation or replacement of electromagnetic bone conduction hearing device in temporal bone.
69714	Implantation, osseointegrated implant, skull, with percutaneous attachment to external speech processor.
69716	Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or resulting in removal of less than 100 sq mm surface area of bone deep to the outer cranial cortex.
69717	Replacement (including removal of existing device), osseointegrated implant, skull; with percutaneous attachment to external speech processor.
69719	Revision or replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, within the mastoid and/or involving a bony defect less than 100 sq mm surface area of bone deep to the outer cranial cortex.
69729	Implantation, osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, outside of the mastoid and resulting in removal of greater than or equal to 100 sq mm surface area of bone deep to the outer cranial cortex.
69730	Replacement (including removal of existing device), osseointegrated implant, skull; with magnetic transcutaneous attachment to external speech processor, outside the mastoid and involving a bony defect greater than or equal to 100 sq mm surface area of bone deep to the outer cranial cortex.

Fitting/Testing and Totally Implantable Middle Ear CPT/UnlistedCPT

92590	Hearing aid examination and selection; monaural.
92591	Hearing aid examination and selection; binaural.
92592	Hearing aid check; monaural.
92593	Hearing aid check; binaural.
92594	Electroacoustic evaluation for hearing aid; monaural.
92595	Electroacoustic evaluation for hearing aid; binaural.
69799	Unlisted procedure, middle ear.
0951T	Totally implantable active middle ear hearing implant; initial placement, including mastoidectomy, placement of and attachment to sound processor.
0952T	Totally implantable active middle ear hearing implant; revision or replacement, with mastoidectomy and replacement of sound processor.
0953T	Totally implantable active middle ear hearing implant; revision or replacement, without mastoidectomy and replacement of sound processor.

1–10 of 12

1/2

HCPCS/CPT/Revenue/V codes for fittings, BAHA components, semi-implantable and wearable devicesmixed

L8690	Auditory osseointegrated device, includes all internal and external components.
L8691	Auditory osseointegrated device, external sound processor, excludes transducer/actuator, replacement only, each.
L8693	Auditory osseointegrated device abutment, any length, replacement only.
L8694	Auditory osseointegrated device, transducer/actuator, replacement only, each.
S0618	Audiometry for hearing aid evaluation to determine the level and degree of hearing loss.
V5010	Assessment for hearing aid.
V5011	Fitting/orientation/checking of hearing aid.
V5014	Repair/modification of a hearing aid.
V5020	Conformity Evaluation.
V5264	Ear mold/insert, not disposable, any type.

1–10 of 15

1/2

Wearable Hearing Aid HCPCS/V codesHCPCSCovered

V5030	Hearing aid, monaural, body worn, air conduction.
V5040	Hearing aid, monaural, body worn, bone conduction.
V5050	Hearing aid, monaural, in the ear.
V5060	Hearing aid, monaural, behind the ear.
V5070	Glasses, air conduction.
V5080	Glasses, bone conduction.
V5267	Hearing Aid or assistive listening device/supplies/accessories, not otherwise specified (requires manual review for coverage).
V5298	Hearing aid, not otherwise classified.
V5254	Hearing aid, digital, monaural, CIC.
V5255	Hearing aid, digital, monaural, ITC.

1–10 of 16

1/2

No codes present in this portion of the documentmixed

No codes listed

Applicable CPT Codes (updated)CPT

0951T	Listed as added applicable CPT code
0952T	Listed as added applicable CPT code
0953T	Listed as added applicable CPT code
0954T	Listed as added applicable CPT code
0955T	Listed as added applicable CPT code

Degree of Hearing Loss (dBHL)

Normal-10 to 15 dBHL

Slight16 to 25 dBHL

Mild26 to 40 dBHL

Moderate41 to 55 dBHL

Moderately severe56 to 70 dBHL

Severe71 to 90 dBHL

Profound

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required — follow InterQual and FDA selection criteria

Prior authorization is required for implantable and semi-implantable hearing devices and other devices when specified by UnitedHealthcare systems. Medical necessity determinations reference InterQual criteria and device-specific FDA selection criteria; providers must follow InterQual AND applicable FDA labeling/selection criteria when requesting prior authorization.

Confirm prior authorization requirements and submit requests using current UnitedHealthcare prior authorization systems.
When InterQual criteria exist for the device (e.g., wearable air-conduction, bone-anchored, semi-implantable devices), include the InterQual rule-set reference in the request.
For FDA-approved implants, document that patient selection meets the device-specific FDA labeling/selection criteria (audiometric thresholds, word recognition scores, age limits, prior hearing aid experience as applicable).
Providers should verify and use the updated CPT codes added 12/01/2025 (0951T–0955T) and any other current codes in UnitedHealthcare systems when submitting claims.

Clinical Background and Evidence Summary

Hearing loss is classified clinically as conductive (problem conducting sound through the outer/middle ear), sensorineural (inner ear or auditory nerve dysfunction), or mixed (components of both). Device categories addressed in this policy include wearable air-conduction hearing aids, bone-anchored / bone-conduction devices (including percutaneous and transcutaneous systems), semi-implantable electromagnetic middle ear devices, laser or light-based contact hearing devices (CHD), and totally implantable middle ear hearing systems.

Device-specific regulatory status and selection criteria vary: for example, semi-implantable electromagnetic devices (Vibrant Soundbridge, Maxum) have FDA approvals with specific audiologic selection thresholds and word-recognition requirements; BAHA/bone-anchored systems are FDA-cleared with indications including conductive or mixed hearing loss and pure tone threshold ≥ 45 dB for certain indications; CHD systems use a light-based transmission mechanism; and totally implantable systems have more limited and mixed evidence regarding efficacy and safety.

Evidence quality and clinical findings vary by device category. Semi-implantable electromagnetic devices (e.g., Vibrant Soundbridge, Maxum) have FDA approvals and professional labeling with defined selection criteria (age limits, audiologic thresholds, and word recognition scores).

Bone-anchored hearing aids (BAHA and successors) have longstanding FDA clearances and defined indications—such as conductive or mixed loss and a pure tone threshold hearing loss of ≥ 45 dB for some adult indications—and are considered appropriate for selected patients per professional guidance (AAO-HNS).

By contrast, totally implanted middle ear systems and intraoral bone conduction devices are supported by limited or low-quality studies (single-arm designs, small samples, short follow-up) with mixed results and reported device-related issues; therefore the policy finds the evidence insufficient to definitively establish efficacy for those systems.

Key Terms and Device Definitions

Conductive Hearing Loss — definition

DefinitionOccurs when sound is not conducted efficiently through the outer ear canal, tympanic membrane, or ossicles of the middle ear

Functional effectUsually involves reduction in sound level or ability to hear faint sounds

TreatabilityOften correctable medically or surgically

Degree of Hearing Loss / Sensorineural Hearing Loss

Degree of hearing lossRanges from Normal (-10 to 15 dBHL) to Profound (≥91 dBHL)

Sensorineural hearing loss (SNHL)Occurs from damage to cochlea or auditory nerve and is usually permanent; often not correctable medically or surgically

Policy History and Revisions

12/01/2025codes_updatedLatest

Updated list of applicable CPT codes to reflect quarterly edits; added 0951T, 0952T, 0953T, 0954T, and 0955T.

12/01/2025prior_version_archived

Archived previous policy version CS052KY.10.

The policy history notes that applicable CPT codes were updated on 12/01/2025 to add codes 0951T, 0952T, 0953T, 0954T, and 0955T. Providers should confirm current prior authorization requirements and code edit rules with UnitedHealthcare and the member’s specific plan.

Providers must supply appropriate procedure and diagnosis coding as listed in the Applicable Codes section when submitting requests for prior authorization or claims; inclusion of a code in the policy does not guarantee coverage and prior authorization rules may vary by plan and state.

Policy Summary

PayerUnitedHealthcare

PolicyHearing Instruments and Devices Including Wearable, Bone-Anchored, and Semi-Implantable (for Kentucky Only)

Policy CodePolicy CS052KY.11

Change TypeCPT code list updated

Effective DateDecember 1, 2025

Next Review Date

Key ActionObtain prior authorization using InterQual clinical criteria and document device-specific FDA selection criteria when requesting coverage.

SourceLink

On This Page

FDA clearance and indication details should be consulted when evaluating candidacy.

Semi-implantable electromagnetic and bone-anchored devices (Vibrant, Maxum, BAHA, Ponto, Osia, Bonebridge, etc.): Several devices have FDA approvals/clearances with specified selection criteria; AAO-HNS considers these devices appropriate for selected patients when conventional amplification is inadequate.

Device-specific numeric criteria and patient selection described in FDA labeling (see device sections).

Vibrant Soundbridge pure‑tone AC thresholds by frequency

500 Hz30–65 dB

1000 Hz40–75 dB

1500 Hz45–80 dB

2000 Hz45–80 dB

3000 Hz50–85 dB

4000 Hz50–85 dB

BAHA indication — hearing loss threshold and notes

Minimum PTA thresholdPure tone threshold hearing loss of ≥ 45 dB

Pediatric useCleared for children 5 years of age and older (per BAHA FDA clearance)

Bilateral implantationAllowed when moderate to severe bilateral symmetrical conductive loss (symmetry defined per device) or mixed loss with BC averages better than device-specific limits

BAHA SSD normal‑hearing definition

Definition of normal hearing for BAHA SSDPTA air‑conduction threshold ≤ 20 dB measured at 0.5, 1, 2, and 3 kHz

Intended useBAHA for SSD intended to improve speech recognition in unilateral SNHL where opposite ear meets normal hearing definition

Alternative to AC CROSIndicated for patients appropriate for AC CROS but who cannot or will not use an AC CROS

PTA bone‑conduction threshold — device‑specific values

Common device limit (<=45 dB HL)PTA BC ≤ 45 dB HL (measured at 0.5, 1, 2, and 3 kHz) for several BAHA/Bonebridge/Sophono devices

Higher device limit (<=55 dB HL)PTA BC ≤ 55 dB HL for some processors (e.g., specific BP100/BP110 processor models) as specified by device labeling

ADHEAR specific limit (<=25 dB HL)ADHEAR non‑invasive system: PTA BC ≤ 25 dB HL (0.5, 1, 2, 3 kHz)

PTA air‑conduction threshold for contralateral ear (normal hearing)

Common normal contralateral hearingPTA air‑conduction threshold commonly defined as ≤ 20 dB HL (measured at 0.5, 1, 2, and 3 kHz)

Use in SSD indicationsContralateral ear meeting ≤ 20 dB HL AC average is required for SSD indications for many bone‑anchored and semi‑implantable devices

Measurement frequenciesPTA measured at 0.5, 1, 2 and 3 kHz unless device labeling specifies alternative frequencies

Interaural symmetry criteria

Average interaural symmetryDifference < 10 dB average between ears (measured at 0.5, 1, 2, and 3 kHz)

Frequency‑specific asymmetryLess than 15 dB difference at individual frequencies qualifies as symmetric for many device indications

Bilateral fitting requirementBilateral implantation typically requires symmetric BC thresholds per the above criteria

Documentation Required

Document FDA Selection Criteria and Clinical Findings

Document device-specific FDA selection criteria and relevant clinical findings in the prior authorization and medical record. Include audiometric data, word recognition scores, ear/middle ear anatomy, age, prior trial of conventional hearing aids (or documented contraindication), and psychosocial suitability when applicable.

Audiograms with pure tone thresholds at specified frequencies and calculated PTA/BC where applicable.
Word recognition score using recorded materials (e.g., WRS ≥ 50% for some semi-implantable devices per labeling).
Evidence of normal middle ear anatomy for devices that require it.
Documentation of appropriately fitted conventional hearing aid trial OR documented contraindication to hearing aid use when required by InterQual or device labeling.

Denial Risk

Denial Risk for Unproven or Experimental Devices

Denial risk is higher for devices that the policy identifies as unproven or not medically necessary due to insufficient evidence. Submit clear supporting evidence when requesting coverage for nonstandard or investigational devices.

Intraoral bone conduction hearing instruments, laser/light-based hearing instruments, and totally implanted middle ear hearing instruments are listed as unproven — claims for these may be denied.
Intraoral bone conduction devices have insufficient quality evidence and are at risk for non-coverage.

Billing Rule

Coding and Documentation Note

Billing and coding must reflect current applicable CPT/HCPCS codes and diagnosis codes. Include appropriate procedure and diagnosis coding as listed in the policy's Applicable Codes and in UnitedHealthcare systems.

Use the updated applicable CPT codes (policy updated 12/01/2025 to add 0951T, 0952T, 0953T, 0954T, 0955T) and any additional codes required by quarterly edits.
Include diagnosis codes supporting medical necessity and any modifier(s) required for bilateral or staged procedures per billing rules.

Documentation Required

Benefit Determination Requirement — check member-specific plan terms

Benefit determinations depend on the member's federal, state, or contractual benefit plan terms. This policy provides guidance for standard plans but does not replace plan-specific coverage rules.

Before approving or denying coverage, verify the member's benefit plan, state/federal requirements, and any contractual provisions that may alter coverage.
In case of conflicts between this policy and benefit terms, federal/state/contractual requirements govern.

Documentation Required

Documentation and Governance

Document governance and supporting materials in the medical record and prior authorization submission. Maintain records of device labeling references, InterQual decision support snapshots, and any communications with UnitedHealthcare regarding coverage rationale.

Attach or reference the specific InterQual criteria used to justify medical necessity.
Cite the FDA PMA/K-number or professional labeling URL for device selection criteria when applicable.
Retain documentation of prior conventional hearing aid trials or reasons for contraindication.

Step Therapy

Step Therapy / Hearing Aid Trial

Step therapy: there is no explicit step therapy sequence specified in this policy for implantable or semi-implantable devices; however, InterQual criteria may require prior trial of conventional hearing aids or documentation of contraindication. Providers should follow InterQual and plan-specific step/coverage requirements.

When InterQual or device labeling requires a trial of conventional hearing aids, document the trial (duration, device fit, outcome) or document a contraindication to hearing aid use.
Confirm any plan-level step therapy rules in UnitedHealthcare systems prior to authorization; absence of a policy-level step requirement does not preclude plan-specific requirements.

Mixed hearing lossCombination of conductive and sensorineural components (damage in outer/middle ear plus inner ear or nerve)

Hearing Aids / Hearing Instruments — definition

DefinitionDevices designed to aid hearing by amplifying or mechanically stimulating the ear; includes wearable air‑conduction aids, semi‑implantable electromagnetic devices, and bone‑anchored devices as classified by FDA

Included technologiesSemi‑implantable electromagnetic hearing aids and bone‑anchored hearing aids are classified as Hearing Aids for this policy

ComponentsMay include internal and external components, processors, abutments, transducers, and accessories referenced in coding and device labeling

Intraoral bone conduction hearing aid (IOBC) — definition

DefinitionNon‑surgical intraoral bone conduction system with behind‑the‑ear processor and removable oral retainer that transmits sound via the teeth and skull to the cochleae

Intended populationDeveloped for single‑sided deafness (example: SoundBite)

Availability noteSoundBite manufacturing ceased after manufacturer bankruptcy (no longer produced as of 2015)

Laser or light‑based contact hearing device (CHD) — definition

DefinitionSystem using a light‑based behind‑the‑ear processor that transmits infrared light to a tympanic membrane transducer placed in the ear canal, converting light pulses to mechanical vibrations

ComponentsConsists of a BTE light‑based sound processor and removable custom tympanic membrane transducer (Earlens CHD example)

MechanismLight pulses are converted to vibrations applied directly to the tympanic membrane rather than amplifying air‑conduction sound

Totally implantable middle ear hearing system — definition

DefinitionImplanted system with internal sound processor, sensor, and driver placed in/behind the middle ear that directly stimulates the inner ear without external microphone/speaker

ComponentsIncludes implanted processor, sensor, and driver; powered by internal maintenance‑free battery in examples like Esteem

Distinctive featuresDoes not use external microphone or speaker and is fully implanted compared with semi‑implantable systems

Single‑sided deafness (SSD) — definition and normal‑hearing parameters

DefinitionUnilateral sensorineural deafness in one ear with normal hearing in the opposite ear

Normal‑hearing parameterContralateral ear defined as PTA AC threshold ≤ 20 dB HL at 0.5, 1, 2, and 3 kHz for device SSD indications

Use casesSSD indications include patients who are candidates for AC CROS but cannot or will not use an AC CROS

Pure tone average (PTA) bone‑conduction threshold — definition

DefinitionAverage of bone‑conduction thresholds measured at 0.5, 1, 2, and 3 kHz (4 kHz may be used when specified)

Device labeling useMany device indications specify maximum acceptable PTA BC thresholds (e.g., ≤45 dB HL, ≤55 dB HL) for candidacy

Measurement notePTA BC is used to determine candidacy for bone‑anchored and partially implantable devices per FDA labeling