Auditory Outcomes in Children Who Undergo Cochlear Implantation Before 12 Months of Age: A Systematic Review

Abstract

Objective

To systematically review the literature to determine auditory outcomes of cochlear implantation in children ≤12 months old.

Data Source

PubMed, EMBASE, Medline, CINAHL, Cochrane, Scopus, and Web of Science databases were searched from inception to 9/1/2021 using PRISMA guidelines.

Review Methods

Studies analyzing auditory outcomes after cochlear implantation (CI) in children ≤12 months of age were included. Non-English studies and case reports were excluded. Outcome measures included functional and objective auditory results. Two independent reviewers evaluated each abstract and article. Heterogeneity and bias across studies were evaluated.

Results

Of 305 articles identified, 17 met inclusion criteria. There were 642 children ages 2 to 12 months at CI. The most common etiologies of hearing loss were congenital CMV, meningitis, idiopathic hearing loss, and GJB2 mutations and other genetic causes. All studies concluded that early CI was safe. Overall, outcomes improved following early CI: IT-MAIS (9 studies), LittlEARS (4 studies), PTA (3 studies), CAP (3 studies), GASP (3 studies), and LNT (3 studies). Nine studies compared outcomes to an older implantation group (>12 months); of these (n = 450 early CI, n = 1189 late CI), 8 studies showed earlier CI achieved comparable or better auditory outcomes than later implantation, whereas 1 study (n = 120) concluded no differences in speech perception improvement.

Conclusion

Auditory outcomes were overall improved in children ≤12 months old undergoing CI. Studies that compared early to late CI demonstrated similar or better auditory outcomes in early implantation group. Given the comparable safety profile and critical time period of speech and language acquisition, earlier CI should be considered for infants with hearing loss.

Universal newborn hearing screens have been instrumental in early identification of hearing loss in newborns, thus allowing for early intervention. In 2020, the age of approval for cochlear implantation (CI) was decreased to 9 months by the U.S. Food and Drug Administration (FDA) for children with bilateral profound sensorineural hearing loss.¹ Sensory input in these early months is crucial in order to take advantage of children's developmental period of neural plasticity.² Fitting of amplification in children aged 1 to 72 months has been shown to have a pronounced influence on speech perception and production.³ Many centers are increasingly implanting infants at younger ages given this window of opportunity for development of auditory pathways, speech, and language.^{4, 5}

One of the concerns with early implantation has been the safety of CI in these young infants. A recent meta-analysis demonstrated a 2.3% rate of major complications in infants undergoing CI, which were most commonly device failure, cerebrospinal fluid leak, device migration, and infection.⁶ There were few reports of blood transfusions, temporary facial paralysis, and revision surgery. Most complications were resolvable and this rate is comparable to that of complications in older cohorts, highlighting the safety of this procedure in infants. Moreover, 1 study showed that patients with surgical complications achieved comparable and satisfactory postoperative auditory outcomes to patients without complications.⁷

Although the safety of early implantation has been shown, the impact on auditory outcomes is less understood. There are challenges with audiological assessment of infants before and after CI due to lack of advanced communicative skills that permit accurate feedback and testing. Various auditory measures are used to evaluate these younger children.⁸ Functional auditory outcomes can be assessed by questionnaires completed by parents such as infant-toddler meaningful auditory integration scale (IT-MAIS) and LittlEARS auditory questionnaire (LEAQ). Objective auditory outcomes measure the ability to hear and recognize sound and speech, and can be assessed by tests like categories of auditory performance (CAP), consonant-nucleus-consonant (CNC), lexical neighborhood test (LNT), and Glendonald auditory screening procedure (GASP). A previous meta-analysis assessing auditory performance of these young infants after CI included 9 studies published between 1982 and 2008. This study concluded that there was limited evidence of improved auditory performance and speech production for children implanted before 12 months⁹; however, it was limited by few available studies for query and timing that preceded FDA approval for CI in this age group. Since that time, a greater number of studies have assessed the outcomes of early CI. Therefore, we aimed to systematically review the literature to characterize auditory outcomes in children who undergo CI at ≤12 months of age.

Methods

1 Study Identification

This systematic review was completed according to the Preferred Reporting System and Meta-Analyses (PRISMA) guidelines.¹⁰ PubMed, EMBASE, Medline, CINAHL, Cochrane, Scopus, and Web of Science databases were searched from inception to September 1, 2021 using PRISMA guidelines by a medical librarian. A combination of Medical Subject Headings (MeSH), other controlled vocabulary, and keywords was used to search for pediatric cochlear implantation and outcomes (Appendix A).

2 Eligibility Criteria and Study Selection

After duplicate studies were removed, 2 authors (Wu and Appachi) independently screened titles and abstracts for relevant articles. Next, full texts were analyzed independently (Wu and Appachi) according to the predefined inclusion and exclusion criteria. Studies were included if any patients in their sample were 12 months of age or younger at time of CI and any postoperative auditory outcomes were available. Auditory outcomes of interest included but were not limited to: CAP, IT-MAIS, LEAQ, GASP, LNT, CNC, and Peabody Picture Vocabulary Test (PPVT). Exclusion criteria were single case reports, articles not available in the English language, and studies in which data for patients who were implanted at 12 months or younger were indistinguishable from older patients. Discrepancies between the 2 authors were resolved through discussion to produce a final list of studies for data extraction.

3 Data Extraction and Quality Assessment

The final studies were reviewed for auditory outcomes by 2 independent authors (Wu and Appachi). A data extraction sheet was developed in collaboration with the author group to include the article name, year of publication, study setting, number of patients, age range, comorbid factors, auditory outcomes, and length of follow-up to ensure consistency in data collection. Two authors (Wu and Appachi) completed data extraction sheets for each full-text article independently, and conflicts were resolved through further review and discussion. Final results were compiled into a single spreadsheet for statistical analysis. The Newcastle-Ottawa scale (NOS, score range 1-9) was completed independently by 2 authors (Wu and Appachi) and used to assess each study for risk of bias.¹¹ Studies with a score of less than 6 points were considered to have high risk for bias.

4 Statistical Analysis

The highest observed score for each auditory test, recorded as a percentage out of 100%, was recorded. Heterogeneity in the test scores across studies was assessed using the I² statistic. Because scores for individual patients were not consistently reported, a meta-analysis was not able to be performed. All statistical analyses were performed in R software (version 4.0.3) with p < .05 considered statistically significant.

Results

The librarian search yielded 423 articles, of which 76 were duplicates that were excluded. Of the 347 remaining studies, 262 were initially excluded from further analysis based on title and abstract review, resulting in 79 articles for full-text review. Of these, 62 articles were excluded after manuscript review. The remaining 17 studies were included for data abstraction and ultimately included in the systematic review (Figure 1).^{7, 12-27} These 17 studies were published between 2004 and 2021 (Supplemental Table S1, available online). The mean NOS score was 6.3 (SD 1.6) (Supplemental Table S2, available online).  There were 3 prospective studies and 14 retrospective studies. Study settings were in an academic hospital (14 studies), outpatient hearing clinic (2 studies), and a children's hospital (1 study). Duration of follow-up across all studies ranged from 2 months to 10 years after CI.

Figure 1

Flow diagram of the literature search according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.

1 Study Population

Among the 17 studies, there were 642 children with age range of 2 to 12 months at implantation. Of these, there were 451 patients receiving bilateral and 210 receiving unilateral CI devices. Surgical complications were discussed by 8 studies including 242 children implanted ≤12 months; these included 6 (2.5%) cases of CSF leak, 3 (1.2%) cases of device failure, and 2 (0.8%) cases of infection.^{7, 12, 16, 18, 20, 21, 25, 27} Ten of 17 studies had a comparison group versus infants under age 12 months. Across these 10 studies, there were 452 children implanted at age ≤12 months, and 1189 children implanted at an age older than 12 months. Across all studies reporting on causes of hearing loss, etiologies were as follows: idiopathic (n = 264, 49.3%), GJB2 mutations and other genetic causes (n = 181, 33.8%), congenital CMV (n = 26, 4.9%), meningitis (n = 24, 4.5%), syndrome (n = 24, 4.5%), and other (n = 16, 3.0%).^{7, 12, 13, 16, 18-21, 23-25, 27} Other causes included maternal sepsis, gentamicin, and inner ear malformations.^{7, 12, 21}

2 Auditory Outcomes

Postoperative scores for each study are summarized in Supplemental Table S3, available online. IT-MAIS was reported by 9 studies (Figure 2).^{7, 12, 13, 15, 18-21, 23} Average IT-MAIS score was 73% after CI in children ≤12 months old, with a range of 60% to 90%. LEAQ was reported by 4 studies (Figure 3).^{12, 19, 24, 27} Average LEAQ score was 84% after CI in the ≤12 months cohort, with a range of 80% to 91%. CAP was reported by 3 studies (Figure 4).^{12, 17, 18} Average CAP score was 79% after CI in the ≤12 months cohort, with a range of 80% to 100%. GASP was reported by 4 studies (Figure 5).^{7, 13, 19, 20} Average GASP score was 71% after CI in the ≤12 months cohort, with a range of 55% to 92%. CNC was reported by 3 studies (Figure 6).^{14, 19, 20} Average CNC score was 80% after CI in the ≤12 months cohort, with a range of 65% to 95%. Studies with predominantly bilateral or all bilateral CI reported high auditory scores: Chweya et al, IT-MAIS 81%¹⁹; Guo et al, CAP 90%¹⁷; Ozieblo et al, LEAQ 80%²⁴; May-Mederake, LEAQ 88%.²⁷ Studies with predominantly CI or all unilateral CI reported the following scores: Roland et al, GASP 57%⁷; Valencia et al, IT-MAIS 70%²¹; Yang et al, CAP 80%¹²; Lesinski-Schiedat et al, GASP 30%.¹³

Figure 2

IT-MAIS score after cochlear implantation ranged from 32% to 90% (10 studies). The weighted average of IT-MAIS score was 64% for the ≤12 months cohort. IT-MAIS, infant-toddler meaningful auditory integration scale.

Figure 3

LEAQ score after cochlear implantation (4 studies). The weighted average of LEAQ score was 84% for the ≤12 months cohort. LEAQ, LittlEARS auditory questionnaire.

Figure 4

CAP score after cochlear implantation (3 studies). The weighted average of CAP score was 79% for the ≤12 months cohort. CAP, categories of auditory performance.

Figure 5

GASP score after cochlear implantation (4 studies). The weighted average of GASP score was 71% for the ≤12 months cohort. GASP, Glendonald auditory screening procedure.

Figure 6

CNC score after cochlear implantation (3 studies). The weighted average of CNC score was 80% for the ≤12 months cohort. CNC, consonant-nucleus-consonant.

3 Auditory Outcomes in Studies With Comparison Groups

Ten studies compared outcomes between early implantation ≤12 months and implantation at >12 months. Nine of these 10 studies concluded that earlier CI achieved similar or higher auditory scores than later implantation (Figure 7).^{13, 16-19, 22, 24-26} Two studies with a comparison group for CAP showed a weight average postimplantation score of 87%, compared to 91% for the ≤12-month cohort.^{17, 18} The Colletti et al study reported that both cohorts attained the maximum CAP score by 42 months postoperatively; however, the ≤12-month cohort had significantly higher CAP scores at 12 and 36 months postoperatively.¹⁸ Although the Guo et al study reported nonsignificant differences in highest CAP core at last follow-up at 60 months, the ≤12-month cohort achieved higher CAP scores at the same physical age compared to the >12-month cohort.¹⁷ Three studies reported a comparison group for IT-MAIS,^{13, 18, 19} with a weighted average of 86% and 82% for ≤12 and >12 months cohorts, respectively. The Colletti et al study reported significantly higher IT-MAIS scores in the ≤12-month cohort compared to normative data.^{15, 18} Although the Lesinski-Schiedat study did not perform statistical analysis, IT-MAIS score was 97% at 18 months postoperatively in the ≤12-month cohort, which was not achieved until 24 months postoperatively by the >12-month cohort.¹³ Weighted postimplantation LEAQ scores were 83 and 86% for the ≤12 and >12-month cohorts, respectively, and the differences were not significantly different.^{19, 24} Weighted GASP scores for the 2 studies with a comparison group were 75% versus 59% for ≤12- and >12-month cohorts, respectively.^{13, 19} Finally, weighted postoperative CNC score was 86% versus 83% for ≤12- and >12-month cohorts, respectively.^{14, 19} The Leigh et al study concluded no significant differences, whereas the Chweya et al reported significantly higher CNC scores in the ≤12-month cohort.^{14, 19}

Figure 7

Auditory outcomes after cochlear implantation compared between early (≤12 months old) and late (>12 months old) for CAP, IT-MAIS, LEAQ, GASP, and CNC. p values are reported. CAP, categories of auditory performance; CNC, consonant-nucleus-consonant; GASP, Glendonald auditory screening procedure; IT-MAIS, infant-toddler meaningful auditory integration scale; LEAQ, LittlEARS auditory questionnaire; N/A, not available; ns, nonsignificant. 

4 Speech and Language Outcomes in Studies With Comparison Groups

Favorable outcomes regarding language, vocalizations, and vocabulary were seen, especially when CI was performed ≤12 months of age. Miyamoto et al demonstrated similar language skills between infants who underwent CI at <12 months and normal hearing infants.²⁵ Kishon et al demonstrated improved prelexical vocalizations after CI in infants.¹⁵ Hoff et al showed that compared to implantation at >12 months, children implanted ≤12 months developed open-set words at a younger age and were more likely to develop oral-only communication.¹⁶ Leigh et al demonstrated that language growth rates for infants undergoing CI were equivalent to those with normal hearing.¹⁴ Moreover, these children achieved age-appropriate receptive language scores at 3 years postoperatively compared to those implanted at 13 to 24 months, who had a significant language delay at this time point.¹⁴ This was corroborated by Colletti et al who reported that infants' vocabulary outcomes did not differ significantly from normal-hearing children, whereas the older age groups never reached the values of normal-hearing peers even after 10 years of CI use.¹⁸ Children implanted <12 months produced more intelligible speech earlier than children implanted >12 months old.¹⁸

Discussion

This systematic review of 17 studies showed favorable auditory outcomes overall in children ≤12 months old undergoing CI. Studies that compared early to later age at CI demonstrated comparable or better functional and objective auditory outcomes in the early implantation group. Given the comparable safety profile and critical time period of speech and language acquisition, earlier CI can be considered for infants with hearing loss.

The early months of life are crucial for central auditory development. This is the time period when neural plasticity is highest due to increased synaptogenesis.^{2, 28-31} Previous animal studies have shown that in the absence of auditory stimulation, there can be degeneration across the central auditory system. This includes reduction in synaptic activity in cortico-cortical and cortico-thalamic connections and decreases in the cell densities of the spiral ganglion, anteroventral cochlear nucleus, and the ventral cochlear nucleus.^28-30 In humans, auditory deprivation can cause delayed or abnormal maturation in the auditory cortex, as well as reorganization of the auditory cortex with loss of auditory representation.^{31, 32} Moreover, with loss of auditory stimulation, temporal patterns that are important for developing neurocognitive skills, such as pattern detection, sequential memory, and sustained attention, could be affected.³²

Given the detrimental effects of auditory deprivation, it is widely believed that earlier CI could prevent these degenerative effects and stimulate the development of central auditory pathways at a time of high neural plasticity. This hypothesis has been borne out in human studies. Sharma et al studied the P1 component of cortical auditory evoked potentials in patients who underwent CI at different ages.^{2, 28, 30} Children who underwent CI prior to 3.5 years of age had normal P1 latencies within 6 months, whereas children who underwent CI after 7 years of age had abnormal latencies even after multiple years of usage. Children implanted between these ages had significant variation in latencies. This suggests the most optimal and sensitive period for central auditory development and thus for CI is before 3.5 years old.

Other studies have demonstrated that deafness and lack of stimulation of the auditory cortex can lead to reorganization and recruitment of auditory areas for nonauditory functions, and this may be responsible for the difficulties that deaf children have with speech and language.²⁹ This has been demonstrated in children who underwent CI at older ages: they had restricted changes in thalamo-cortical responses and poorer speech perception than those who were implanted earlier in deafness,³³ whereas infants fitted with cochlear implants can achieve success with spoken language comparable to their normal hearing peers.²⁹ Thus, early identification of infants with profound hearing loss and early implantation can stimulate and preserve central auditory development at a time of maximal plasticity. The results of the present systematic review support this finding, as functional and objective auditory outcomes were consistently favorable in children implanted ≤12 months of age. Moreover, in the studies comparing children ≤12 months versus >12 months at CI, auditory outcomes were similar or even better in those undergoing earlier implantation.^{13, 14, 16-19, 22, 24-26} This was especially true for IT-MAIS; children implanted at a younger age scored 12% to 15% higher than those implanted at an older age in 2 of the 3 comparative studies.^{13, 18}

The FDA guidelines approve CI for infants 9 months of age or older with bilateral profound sensorineural hearing loss. Traditional candidates for pediatric CI are those with zero open-set word recognition. Patient selection should take into consideration developmental status as this has been shown to be critical for speech development after CI.³⁴ Not only are word recognition and audiometric data important to assess after pediatric CI, long-term functional outcomes including vocabulary, grammar, speech development, cognition, and academic achievement are important to assess in order to determine the impact of CI on users' functioning in daily life. Expansion of candidacy, including younger age at implantation, is being explored to determine additional patients who may benefit from CI under less stringent criteria.^35-37

Long-term language outcomes were also available for some of these studies.¹⁸ Colletti et al reported that vocabulary development 10 years post-CI in those implanted at ≤12 months was closest in language age to normal hearing children, followed by CI at 12 to 24 months. CI at 24 to 36 months had the largest gap in vocabulary from normal hearing. Additionally, at 5 and 10 years after CI, grammar development for CI at ≤12 months was closest to children with normal hearing, whereas CI at >12 months were all below the 75th percentile.¹⁸ Chweya et al had mean follow-up of 8.2 and 8.1 years for 9 to 12 and 12 to 36 month cohorts, respectively, and demonstrated that at last follow-up, the percentage of children utilizing auditory oral communication was 92% for CI at ≤12 months and 89% for CI at >12 months (p = .75).¹⁹

There are several surgical considerations for CI in infants. From an anesthesia standpoint, infants are more vulnerable to hypothermia, airway collapse, fluid imbalance, and hemodynamic instability.^{38, 39} Respiratory complications of laryngospasm, bronchospasm, and aspiration are important to monitor as part of pediatric perioperative care.⁴⁰ Surgical complications may include skin erythema, flap necrosis, CSF leak, facial nerve palsy, and device migration,^41-45 as recently systemically reviewed.⁶ In the 17 studies included in the present systematic review, surgical complications were disclosed by 8 studies, which included a 0 to 6.6% rate of complications. Notably, the study with the highest (6.6%) rate of complications were 4 cases of CSF leak in the <12-month group, and this study was predominantly (95%) bilateral rather than unilateral CI.¹⁶ A prior study by Uecker et al concluded that there were no differences in complications when comparing 32 patients undergoing simultaneous CI versus 22 patients undergoing sequential CI, despite the longer cumulative operative time in sequential.⁴⁶ Future studies are needed to determine the safety of simultaneous bilateral versus unilateral CI.

Anatomic considerations for CI in infants include delicate skin, thinner skull, smaller mastoid bones, greater mastoid marrow content, and closer distance of facial nerve to skin.^47-49 Greater marrow content predisposes to blood loss during mastoidectomy in infants and thus careful attention to hemostasis is needed. Infants have underdeveloped mastoid tip anatomy, which also warrants precaution for facial nerve injury and emphasizes the importance of intraoperative nerve monitoring.^{50, 51} Gentle soft-tissue handling is critical to prevent complications with wound breakdown More posteriorly-based surgical incisions and gentle soft-tissue manipulation of the flap have been described to optimize safety in infants who have divergent surgical landmarks from older children and adults.^52-55 Lastly, if drilling a well for the receiver-stimulator, consideration must be given to the infants' thin skull.

With current FDA approval for CI set for children aged 9 months of age or older with profound bilateral sensorineural hearing loss, it remains a question on whether implantation at even younger ages incurs additional benefits. In this review, there were several studies reporting on implantation in children at under 9 months old. Valencia et al studied children undergoing CI with a mean age of 9.2 months (range 6.7-11.7) amongst 14 patients, 8 of whom were implanted at 9 months or younger.²¹ Of the 4 patients with available postoperative IT-MAIS scores, 3 achieved satisfactory scores, suggesting a benefit. Chweya et al showed that LNT scores were significantly better in CI < 9 months versus 9 to 12 months (94 ± 4% vs. 86 ± 10%, p = .028).¹⁹ The study by Colletti et al included younger children, with an average age at implantation of 6.4 months (range, 2-11 months).¹⁸ In this study, the infant group had significantly higher scores on IT-MAIS (p = .015), PPTV-R (p = .006), CAP (p < .05), SIR (p = .02), and TROG (p = .001) at long-term follow-up, compared to 12 to 23 month implanted cohort. The 18 children in the study by Waltzman et al were implanted at an average age of 9.6 months (range, 7-11 months), 7 of whom were implanted at ≤9 months.²⁰ The cohort achieved a mean postoperative IT-MAIS score of 76%. There is no consensus on the lower limits of age at CI. A study by Colletti et al reported on a small case series of 12 patients who received CI at ages 2 to 6 months old. These patients achieved the highest scores on CAP, word and sentence comprehension, speech production, phonetic inventory, and receptive language relative to older peers at 48 months postoperatively (p < .05).⁵⁶ Overall, these studies suggest favorable auditory outcomes with even earlier implantation of 9 months or younger. However, surgeon skill is critical to safely perform CI in young infants. Future studies with larger sample size, long-term follow-up, and evaluation of surgeon experience are needed to investigate the safety and outcomes of very early implantation.”

1 Limitations

Although the strengths of this systematic review lie in the large number of children included, recent publication dates, and availability of comparison groups in many studies, there were several limitations. There were no randomized studies or prospective clinical trials available for review. Four of 17 studies were determined to have high risk of bias.^{15, 21, 24, 25} Hearing loss etiology may have confounded the timing of early versus later implantation. Similarly, sequelae of meningitis, congenital CMV, and other disorders that impair neurocognitive functioning could affect language outcomes, but would impact both early and late cohorts similarly. Further studies are needed to elucidate the impact of neurocognitive impairment on outcomes in addition to age at CI. A variety of cochlear implant devices were employed with potential differences in surgical technique. Finally, standard deviations for mean scores and individual scores were infrequently reported and thus a meta-analysis could not be performed. Despite these limitations, the systematic review shows that postoperative auditory scores in CI ≤ 12 months were consistently favorable.

Conclusion

Overall, this systematic review of 642 children across 17 articles suggests favorable auditory outcomes with CI in infants ≤12 months of age, a crucial time period for neural plasticity and auditory development. In 10 studies with the availability of a comparison group, similar or superior auditory and language outcomes were consistently reported for earlier implantation compared to CI after 12 months of age. These positive outcomes with early CI are further corroborated with evidence supporting other improved benefits, specifically with speech perception, vocabulary, receptive language, increased morphemes, utterances, and expressive language in older children. Lastly, the improved benefits do not seem to be at the expense of safety as equivalent safety profiles have been shown with CI at early versus later age in life. Given the safety of this procedure in infants and critical time period for speech and language acquisition, earlier CI should be considered for infants with hearing loss. Future studies should investigate appropriate patient selection for early cochlear implantation and long-term outcomes.

Author Contributions

Shannon Wu, data acquisition, interpretation, analysis, drafting; Firas Sbeih, data acquisition, interpretation, drafting; Samantha Anne, conception, interpretation, drafting, revisions; Michael S. Cohen, interpretation, drafting, revisions; Seth Schwartz, interpretation, drafting, revisions; Yi-Chun C. Liu, interpretation, drafting, revisions; Swathi Appachi, data acquisition, interpretation, drafting, revisions.

Disclosures

Competing interests

M.C. has a sponsored research agreement with Med-El. None of the other authors have significant conflicts of interest with any companies or organizations whose products or services may be discussed in this article.

Sponsorships

None.

Funding sources

None.

Appendix A

Search terms.

[“cochlear implants”] or [“cochlear implantation”] and (cochlea or cochlear) and (implant* or prosthes* or prosthetic*) and [(“1 month*” or “2 month*” or “3 month*” or “4 month*” or “5 month*” or “6 month*”) and (age or old)] or [(“7 month*” or “8 month*” or “9 month*” or “10 month*” or “11 month*” or “12 month*”) and (age or old)] or [“infant, newborn”] or [(“one month*” or “two month*” or “three month*” or “four month*” or “five month*” or “six month*”) and (age or old)] or [(“seven month*” or “eight month*” or “nine month*” or “ten month*” or “eleven month*” or “twelve month*”) and (age or old)] or (“less than” or before) and ((“1 year*” or “one year*” or “12 mos” or “12 month*”) and (age or old))